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Thanks. How frequently would they require a transfusion without any ESA use?
Jul 14, 2010. 12:31 PM | 0 Likes |Link to Comment
> ngrunes, I think you should have written this article :)
Time is a little tight for me now, but I intend to give your questions a thorough response.
You're very kind, and I look forward to it. 10a-d are the specific outstanding questions for you.Jul 14, 2010. 10:24 AM | 0 Likes |Link to Comment
Thanks biotecher --
The Ofsthun et al. study doesn't appear to indicate anything regarding ESAs. Apparently all patients were treated with ESAs. "Mean albumin was higher in the upper hemoglobin categories, as was transferrin saturation." Any number of health correlates could be associated with hemoglobin levels. This was a retrospective view of ESRD [end-stage renal disease] patients that didn't test treatment with ESA relative to placebo. ESRD patients with lower hemoglobin levels may simply have been sicker. I fail to see any conclusion that treatment with ESAs to attain that 11-13 blood level follows from the study, as all patients appear to have been in the midst of ESA treatment. If you look at Table 3 and Figure 1 on page 1911 of that study, comparing time to death and mean rHuEPO treatment, isn't one unfalsified hypothesis that simply higher ESA administration is associated with faster death?
"The other question is - is it really hemoglobin that we should be concerned about?"
Exactly. All recent studies of ESAs seem to suppose that ESAs impact hemoglobin levels and nothing else. Of course then some dosing of ESAs will be found preferable. And that's a ridiculous supposition. It's obviously a ridiculous supposition when ESA use to target 12-14 g/dL has been associated with higher deaths than ESA use to target 9-12 d/gL while normal levels are above 12, right? Isn't that ipso facto evidence that ESAs are potentially lethal for a reason aside from the hemoglobin level they engender?
"The availability of the first ESA, Epoetin, was hailed as a major medical breakthrough in 1989 when, for the first time in history, anemia could be treated without blood transfusion. Dialysis patients used to have hemoglobin levels below 9 unless they received frequent transfusions; they were feeling weak, sick, and were dying quicker. ESAs improved their quality of life significantly without the need for a blood transfusion."
The FDA suggested in that testimony, "Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo."
The simple question -- regardless of what is generally believed as to ESA action, based on what large-scale studies do ESAs reduce blood transfusions significantly and prolong life materially relative to placebo? Surely when Epoetin was first approved, some such large-scale study was conducted?Jul 13, 2010. 11:20 PM | 0 Likes |Link to Comment
Vivus, Arena and Orexigen Investors All Worried About Qnexa FDA Panel Review [View article]Jul 13, 2010. 10:26 AM | 0 Likes |Link to Comment
Vivus, Arena and Orexigen Investors All Worried About Qnexa FDA Panel Review [View article]
Cognitive side effects of Topiramate render it grossly unfit for a weight loss drug. Contrave and Lorcaserin might be decent alternatives.
Now my question:
Cardiac issues appear precisely what Lorcaserin patients *don't* need to worry about. I'd enjoy a comprehensive comparison of the side effects of Contrave and Lorcaserin that focuses not at all on questions raised or trading sentiments, only on the empirical results of clinical studies.
Well, I failed to state that in the form of a question :)Jul 13, 2010. 01:31 AM | 0 Likes |Link to Comment
Thanks Joseph and biotecher –
"This is with regard to ngrunes' key question: "Would FDA approve it (Hematide)?"
My key question is whether the FDA *should* approve it. By "should" I don't mean whether we expect the FDA to approve it, or any probability associated with that expectation; I mean what we think should happen for patients' benefit. I'll break down that question here.
"Your primary argument against Hematide approval is not the fundamentals of safety or efficacy; you seem less concerned with those parameters; your concern is how Hematide will appear in light of the FDA sentiment about ESAs changing."
My concern is precisely with safety, efficacy and value. I see I didn't well communicate what I mean by worst(a,b). Let me clarify that. Continuing the numbering for convenient reference, I'll briefly address (4) valuing biotechs, (5) worst(a,b), (6) my key question, (7) Affymax's trial results, (8) other ESA trial results, (9) what I suggest the FDA do, and (10) the questions for you.
4. Binary outcomes are no impediment to valuation if we reasonably handicap the outcomes. For example, and these numbers are wholly made up just for example, suppose we reasonably conclude based on global averages and clinical trial results that some drug has around a 60% probability of approval and will generate 30% pretax cash earnings on annual sales of $250-500 million for eight years. That's a straightforward expected value. Of course, what management will do with that probabilistic cash is a huge valuation input, as is development cost. Still, if we can estimate (i) probability of approval and (ii) resulting sales and margins even within a large range, the binary outcome per se presents no impediment to fundamental valuation.
5. From your responses I can see I explained worst(a,b) poorly. By worst(a,b) I mean the worst of (a) or (b) (written like it's a spreadsheet formula). In using worst(a,b) for investing, I mean to use the worst of (a) or (b) where:
(a) = what we expect to happen, period. That expectation may incorporate probabilities, such as binary outcomes. But it is simply what we expect as dispassionate observers of facts. This would include our estimate of the probability of any FDA action.
(b) = what we would like to see happen if we're both financially disinterested in the matter and benevolent leaders who control the world. Really.
Using worst(a,b) means we use (a) when we expect a company to do less well than we think it ought to do in an enlightened world (for example, due to corruption or dumb rules impeding it), and, and perhaps more often, we use (b) when we think a company isn't really helping people or regulators are foolishly asleep.
Critical point #1 here: (a) is absolutely irrelevant to (b). B is what we think should happen in an ideal world. That's totally separate from what we think will happen.
Critical point #2 here: defining (b) can be very helpful notwithstanding it entails setting aside reality. It can avert incentives on our part to impede good policy. It can also avert adverse financial outcomes insofar as regulators *or* customers wake up. It's a pleasant way to invest, to exclusively own companies that we think deserve to do well (that's the b), beyond our analysis that we think they will do well probabilistically (that's the a). To invest on the basis of (a) means we think a company will do well. To invest on the basis of (b) means we think a company deserves to do well.
Critical point #3 here: if we use worst(a,b) consistently, then we need to specify (a) and (b) as defined above per investment case.
6. And (b) was my key question: what should happen with Hematide for patients' benefit?
7. We can tackle that question by reviewing salient facts from the trial results that Joseph well summarized and a few other significant trials that caught the FDA's attention. First, the Hematide trials (www.investors.affymax....):
7a. Hematide bulls may say that Hematide was found bioequivalent and non-inferior to Epoetin in the Emerald 1 & 2 trials of dialysis patients.
7b. Hematide apparently was found similarly efficacious to Darbepoetin, but caused more Serious Adverse Events (SAEs) and particularly adverse cardiovascular events than Darbepoetin, in the Pearl 1 & 2 trials of non-dialysis patients.
7c. Given just those statements, one might conclude that Hematide should be approved for dialysis patients and not, at least not yet, approved for non-dialysis patients. I do not conclude that yet, because I see, just at a glance, three problems with the trial results:
7d1. The difference between the structure of the Emerald and Pearl trials (they give clinical trials of potentially lethal drugs such wonderful names, don't they?) was not just dialysis patients vs. non-dialysis patients. Emerald trials of dialysis patients exclusively compared Hematide with Epoetin, whereas Pearl trials of non-dialysis patients exclusively compared Hematide with Darbepoetin. One possibility is that Hematide is non-inferior to any ESA for dialysis patients. But another possibility is that Hematide is inferior to Darbepoetin for patients whether dialysis or non-dialysis. That possibility can't be ruled out from the trial results, as Hematide was found inferior to Darbepoetin in all trials in which they were compared (Pearl 1 & 2). And Darbepoetin is used for patients both on dialysis and not (source: aranesp.com). I don't mean to do Amgen (no position, ever) any favors here. That's just a fact that Hematide was not found non-inferior to Darbepoetin for any indication.
7d2. It wasn't just the headline cardiovascular events that made Hematide inferior to Darbepoetin; Hematide patients also received more red blood cell transfusions (10-11%) than Darbepoetin patients (5%) and had more overall serious adverse events. Hematide wasn't shown to be non-inferior to Darbepoetin for any indication in any endpoint. And Hematide wasn't shown to be efficacious for any indication that Darbepoetin isn't already used to treat.
7d3. I gather the sole purpose of these drugs is to avoid red blood cell transfusions, and yet around 10% of Hematide patients across the trials received RBC transfusions. Roughly what percentage of patients would have received transfusions without Hematide? The trials absurdly don't answer that question, because in no trial was there a control group of no-ESA patients. In other words, the trials don't indicate whether these drugs serve any purpose whatsoever.
8. That could be alright if Epoetin or Darbepoetin was already demonstrated to be convincingly helpful. On first glance, they haven't been. Widespread use does not constitute any such demonstration. Testimony in the House addressing ESAs (fda.gov/NewsEvents/Tes...) just over three years ago noted:
"In February 2007, FDA notified health care professionals of the results from a large clinical trial evaluating the use of an ESA to treat anemia in cancer patients not receiving chemotherapy. In this trial, patients received either Aranesp [Darbepoetin] according to the approved dosing regimen or a placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo."
Well, isn't the sole purpose of ESAs to reduce transfusions? Regardless of whatever is believed as to their action, if they empirically do not, then why are they approved at all?
Now, perhaps that's an erroneous summary of the trial and "placebo" actually means treatment with a lesser amount of ESAs. The significant trials to which I referred in the prior post compared only one dosing of ESAs with another dosing of ESAs, never with no-ESA-at-all.
And that's been the damn ridiculous feature of every significant ESA trial that I saw at a glance. Not one of these trials had a control group of no-ESA-treated patients.
9. Now if I ran the FDA, I would be mildly annoyed at pissants like me questioning our diligence, and yet feel like like an utter fool, and apologize profusely to the public, for tolerating these trials of multi-billion-dollar drugs that compare only one dose of the drug with another dose of the drug, with no control group ever. I would be inclined to invite the public to spank me. Then I would fix it.
Hematide, Epoetin and Darbepoetin should be tested on dialysis and non-dialysis patients with an absolute control group that does not use any ESA before or during the trial. That no-ESA-treatment control group should be a significant size.
Before we have any such trial, we can't know empirically whether these drugs are worth a damn. Practitioners who prescribe these drugs might guess that they reduce need for blood transfusions significantly and that risks attending them are no worse than risks attending transfusions, even less. But we seem to have no data, from any trial on a significant scale, that indicates that.
We do know that higher doses of ESAs are associated with higher deaths. Consistently.
In not requiring control groups of no-ESA-treated patients alongside ESA patients in large scale trials, it appears the FDA has been derelict. And for a multi-billion-dollar class of drugs, it would appear inexcusable to remain derelict.
10. My questions for you remain these few:
10a. What are your guesses, with explanation of the rationale of your guesses, of (i)-(vi) at 2e above that break down expected Affymax cash at Hematide PDUFA date before capital raises?
10b. What are the weblinks to large-scale trials that demonstrate non-inferiority of any ESA -- Epoetin (Epogen/Procrit), Darbepoetin (Aranesp) or Hematide -- to treatment with no-ESA-at-all on the endpoint of serious adverse events?
10c. If you find no such trial, and if your sources find no such trial, are you compelled to agree that the FDA has been derelict in overseeing this class of drugs?
10d. Let's focus on the (b) in worst(a,b). Please review 7d1-7d3. After you reflect on those facts in 7d1-7d3 above, what do you think should happen with Hematide for patients' benefit: For patients' benefit, should it be approved for dialysis patients without requirement of further trials? Or for dialysis patients' benefit, should it be required to be tested for non-inferiority vs. Darbepoetin and a no-ESA control group in dialysis patients before approval, as Hematide has not been found non-inferior to either?Jul 13, 2010. 01:16 AM | 0 Likes |Link to Comment
Thanks Joseph --
To reply to your keen comments above:
"Let me summarize your points as I understand them: "The market's response is to the safety concerns from the trial data is appropriate because...."
Your first paragraph there is an excellent summary of one line of reasoning, and it's not quite mine. Let me summarize (1) what I'm looking for in terms of analytical endpoints, (2) AFFY net cash value at a glance and (3) the key question.
1a. I'm not interested in the market response. I view Mr. Market like Ben Graham -- as a manic-depressive fellow -- though less charitably: as an intoxicated manic-depressive fellow.
1b. Wild price swings like this can reasonably pique interest that Mr. Market is acting especially nutty, but that's it: the question then, whatever the idea source, is investment merit.
1c. Investment merit boils down to three endpoints of analysis: risk bucket, sensible expected value estimate (V), and price (seekingalpha.com/symbol/p). Risk bucket guides portfolio allocation. Price divided by sensible expected value estimate (P/V) determines investment merit.
1d. I mean by V: Expected Value to one who owns the investment for keeps. That must be the definition of value if the investor is to own securities without dependence on Mr. Market for satisfaction. Then the investor can trade with Mr. Market opportunistically and without concern of his mood swings. (Long/short and leveraged market participants, if their lenders require frequent measurement of marketable prices, have no such luxury.)
1e. "Price is what you pay, value is what you get." Price is readily ascertainable. Value is what we analyze. Price is irrelevant to an investment case until we have an expected value estimate.
1f. When we have an expected value estimate, we won't think of the stock in terms of $6 or $23. Simply, we'll view Price divided by Value. We know the Price is around $150 million.
1g. Any price action -- even a 99.9% drop -- cannot inform our Expected Value estimate per 1d above. An investment case boils down to risk bucket, expected value, and price. Expected Value if held for keeps is exogenous of price. Expected Value if held for keeps is the primary endpoint of investment analysis.
1h. I have a further requirement that guides my questions, with which most investors might disagree: by Value I mean the worst of (a) the reasonably expected and (b) our provisional view of what would transpire with enlightened behavior. Others constrict analysis to (a) alone. By using worst(a,b), we accomplish two things. First, we avert incentives to impede what we consider beneficent public policy. I think that's sensible to do, because investors influence much of the world and I want to shape a world for my family that I like. Second, we avert many adverse outcomes. For example, if, a few years ago, we knew that one oil major had a persistently terrible safety record relative to the others, and concluded (a) it'll likely generate $10-15b free cash for several decades and yet (b) in an enlightened world would be fined out of existence, then we would have used worst(a,b)=a for bearish position evaluation and worst(a,b)=b for ownership evaluation. Therefore we wouldn't have owned it and would have avoided cost of a big spill. Similarly, the first question in evaluating Phase III biotechs may be (a) is the FDA likely to approve its candidate and (b) in an enlightened world, would the FDA approve it -- should, for patients' benefit, it be approved and commercialized based on its safety, efficacy and cost relative to best alternatives. Evaluating (a) isn't enough. (b) is my question. Any sensible answer to that question must be based not on general practices or marketplace sentiment but on verifiable facts.
2a. Cash position: at the last reported quarter (Mar10), AFFY had $168m cash+investments+recei... and $128m liabilities of which $58m remained deferred revenue. Typically, you know, deferred revenue is associated with future costs: it can't be held in liabilities simply for tax-timing or income-smoothing purposes. In line with that general verity, you see deferred revenue recognition reduced AFFY cash $14m in the Mar10 quarter beyond P&L net loss. Indeed however the cash appears unrestricted, and so we can evaluate the company's future burn and cash balance separately. $168-128+58 = $98m "net cash" (unrestricted cash, government securities, certificates of deposit, apparently insured auction rate securities, and receivables net of all liabilities payable) at Mar10. Let's also give the company credit for $13m prepaid expenses and deferred tax assets given accrued expenses in excess of that, and call it $111m "net cash".
2b. Investments are both pictures and movies, which is to say: that cash balance is one frame in an ongoing film, which is to ask: what will it be in the foreseeable future.
2c. Affymax received $30m in Jun10 for Phase 3 trials database lock, and, based on trailing quarters, appears likely to have spent near $41m in the June quarter. At June 30, 2010, then: subtract $11m leaving $100m "net cash".
2d. Affymax will receive another $20m if&when FDA accepts Hematide NDA, and we can guess spend $20m/quarter before additional clinical trials or commercialization costs. (Quarterly G&A of $9m may be unlikely to decline amidst NDA activity, while quarterly R&D of $33m of which $13m were outside clinical trial expenses may unlikely be cut materially below $10m. I would direct the company to spend a fraction of that, but my preference is irrelevant to typical biotech operations. In evaluating expenses for long purposes, worst(a,b)=a: not what we would prefer, only what we expect.) Say the NDA is at least accepted for consideration. Unless you expect it to be decided before June 2011 -- and it hasn't even been filed yet -- then fast-forwarding to June 30, 2011 we can envision +$20m -$20m*4 = -$60m cash movement, taking around $100m "net cash" at Jun10 to $40m *before* any additional clinical trial costs. That's just under $1.7/share. And if (as) that estimate is wrong, we might expect burn to more likely than not exceed that absent credible guidance to the contrary.
2e. If you have a higher view of its probable net cash at PDUFA decision date excluding any future capital raise, how do you arrive at it? Let it start with ~ $100m "net cash" at Jun10; add $20m upon NDA admission; and suggest NDA submission at D1 date, PDUFA at D2 date, and average quarterly cash expenses of $Q until then (in estimating $Q, note the company forecasted quarterly G&A to rise from $9.4m for NDA and commercialization activities):
(i) Your estimate of D1 date:
(ii) Your estimate of D2 date:
(iii) Your estimate of $Q:
(iv) Number of quarters from June 30, 2010 to D2 date:
(v) iii * iv = foreseeable estimated burn
(vi) $100m + $20m - (v) = AFFY "net cash" estimate at Hematide PDUFA date before future capital raises or clinical trials.
A snapshot of the current cash position wouldn't answer this question as to Affymax's net cash in the foreseeable future. To decline to view the company as an unfolding movie would be to fight reality. If you take a different view than my $1-2/share net cash estimate of (vi), what are your quick estimates of (i) - (vi)?
3a. The key question is (b) from 1h above: in an enlightened world, would the FDA approve it.
3b. You're very kind in imputing to me any knowledge, but I didn't even know what anemia is until I read your post and associated material yesterday. My only thoughts on this key question derive from reading the company's recent SEC filings until that risk factor noting FDA review of the class of drugs, then googling to the few links noted above. I'm about the last person in the world you would want to query for medical knowledge. What I can do is evaluate elementary reasoning without regard to prevailing sentiment.
3c. The elementary reasoning surrounding this class of drugs ("ESAs" for erythropoiesis-stimula... agents, wherein the E word means producing red blood cells) appeared astounding.
That FDA backgrounder from the FDA's 2007 reconsideration of ESAs (<www.fda.gov/ohrms/dock...;;) included this helpful summary:
"Erythropoiesis-stimul... agents (ESAs) were originally developed to replace the deficiency of erythropoiein that frequently develops in patients with CRF [chronic renal failure, renal Latin for kidneys because it would be too easy to call it kidney failure]. In these CRF patients, ESA administration was shown to increase the red blood cell count (as measured by blood hemoglobin or hematocrit values) and reduce the need for red blood cell transfusion.
Two ESA products are licensed in U.S. and one of these products is marketed under two names, Epogen/Procrit. The other ESA, darbepoetin alfa, is marketed solely under the proprietary name, Aranesp.
Following the initial approval of ESAs, randomized, controlled clinical trials showed that the use of ESAs to attain higher, compared to lower, hemoglobin/hematocrit levels was associated with an increased risk for mortality and serious cardiovascular risks." That means death.
That's the FDA writing in 2007. In other words ESAs were approved only because they reduced need for blood transfusions, and subsequent studies found them to be dangerous. Indeed, all major studies referenced found larger ESA administration to be associated with more deaths.
Further study seems to have confirmed that. See, e.g., that <content.nejm.org/cgi/c...;;.
Three doctors writing from the FDA confirm that in May 2010: "These trials compared ESA dosing strategies that achieved higher hemoglobin targets with those that achieved lower ones,1,2,3 [references] and in each trial, the higher target was associated with a worse outcome. However, these higher targets exceeded recommendations in ESA labeling. The recommended hemoglobin target has never been compared with placebo in a trial of sufficient size to assess cardiovascular outcomes [deaths]." (That's from <content.nejm.org/cgi/c...;; page bottom.)
What's astounding is the sentence that follows that: "Given the plausible symptomatic benefits of higher hemoglobin levels and some evidence of better outcomes, it still appears that randomized trials are needed that compare lower targets, lower ESA doses, and less aggressive dosing strategies."
Given clear and consistent evidence that higher doses of ESAs are associated with more deaths, and immediately after stating that ESAs have never been materially tested relative to placebo, the FDA authors suggest conducting tests not of ESAs relative to placebo but of different dosing strategies of ESAs.
This was the astounding feature of every significant trial in that FDA backgrounder: every study compared not ESAs relative to treatment without them, but some dose of ESAs relative to another dose of ESAs. Of course the outcome of every such study must be a prescription for one dose of ESAs or another dose. Such damn ridiculous studies are a drug company's dream.
3d. Here, you see, is my question with regard to the critical (b) from 1h above (that is, whether the FDA *should* approve it):
All significant studies of ESAs, including of Hematide, appear to have tested -- and only tested -- non-inferiority of some dosing of ESAs relative to another dosing of ESAs. Even that "placebo" study used ESAs rather than blood transfusion when patient hemoglobin dipped below a certain level.
Where is the documentation of large-scale studies of chronic renal failure patients, on dialysis and pre-dialysis, that demonstrate non-inferiority of treatment with ESAs -- any of them (Epogen, Aranesp, Hematide) -- relative to treatment without any ESA?
Those are the studies that should undergird this class of drugs. If they exist: please supply the weblinks. If they don't exist, then -- and regardless of what such studies will find -- the FDA has gotten approval of this class of drugs wrong for two decades.
3e. If and when we see those large-scale studies that should undergird use of ESAs for patients with kidney failure, what are the overwhelming quantified benefits of ESAs relative to their cost?
3f. That brings us back to the endpoints of investment analysis: risk bucket, sensible expected value estimate, and price. Value Estimate is the primary endpoint of investment analysis. For value estimate we use worst(a,b), where (a) = the reasonably expected and (b) = our provisional view of what would transpire in an enlightened world. For Affymax, (a) hinges on the reasonably expected probability of FDA approval and commercialization of Hematide, while (b) hinges on the answers to 3d and 3e. At a glance, there appears to be no reasonable investment case for AFFY before we have answers to 3d and 3e. Surely someone who benefits from selling several billion dollars of these drugs per year can answer those questions instantly.Jul 9, 2010. 06:49 AM | 1 Like |Link to Comment
Thanks Joseph --
"My main argument is that AFFY was $23 two weeks ago and under $6 now; what changed, and is it reasonable?"
Right, that doesn't do it for me, because I don't consider prices necessarily sensible before any over- or under-reaction. Equity, rather than cash viewed without regard to liabilities (that will cause greater cash use than accrual losses in due course), would appear to be the relevant indicator of AFFY value excluding Hematide, and that's around $2/share, not $6. With further burn: $1/share. That's over an 80% loss if Hematide is a no-go, without comment on the probability of its approval.
"In much of your response you are attacking ESAs in general..this class of drugs has come under fire because of the side effects and their effiacy criticized as you pointed out. You have provided some very significant data to this end. But the FDA and general medical community still believes them to be effective for their intended purpose of maintaining Hb levels, with the intention of reducing morbitity and mortality."
Right, and you see the FDA aimed to revisit that later this year, and any bullish case that they won't be curtailed ought to be based on facts of cost and efficacy relative to alternative treatment. Where are those facts?
The FDA seems to nail the missing facts here (May 2010):
"The applicability of the results of major ESA outcome trials to the approved use of ESAs is not straightforward. These trials compared ESA dosing strategies that achieved higher hemoglobin targets with those that achieved lower ones,1,2,3 and in each trial, the higher target was associated with a worse outcome. However, these higher targets exceeded recommendations in ESA labeling. The recommended hemoglobin target has never been compared with placebo in a trial of sufficient size to assess cardiovascular outcomes. Given the plausible symptomatic benefits of higher hemoglobin levels and some evidence of better outcomes, it still appears that randomized trials are needed that compare lower targets, lower ESA doses, and less aggressive dosing strategies.
The intersection of ESA dose, dosing strategy, ESA responsiveness, and hemoglobin target is complex, and we plan to hold a public discussion of these issues at an advisory committee meeting. We must get this right; the public health stakes are extraordinarily high."
Those are FDA employees' comments in May 2010. Boom: "The recommended hemoglobin target has never been compared with placebo...." How the heck has a multibillion/year drug been sustained without comparison to no-drug, to transfusions alone, in any significant study?
And here's <wiki.noblood.org/Eryth...(;wiki.noblood.org/Ery...
"generally EPO is still quite expensive (about twice as costly) relative to the cost of blood transfusion, for which EPO is an alternative treatment."
Here's one of the damning studies:
And here's the only intelligent comment I've seen on it (<content.nejm.org/cgi/c...;;;: same thread as above):
"When a drug is found to be toxic as compared with placebo in a large clinical trial, the logical response is to discontinue the drug in clinical practice or to lower the dose as much as possible."
To recap: AFFY may be worth around $1/share if Hematide is a no-go; the FDA may require more studies (i.e., even one decent study) of the safety of this class of drugs relative to transfusions for anemic patients; higher concentrations of this class of drugs appear to cause higher deaths consistently; transfusions alone sound cheaper than these drugs absent evidence to the contrary; and you have the little issue of those extra deaths on Hematide, which in my mind are almost beside the point that the value and safety of this class of drugs appear unmeasured relative to blood transfusions alone. If they are indeed unmeasured (and this would be a surprise to me, as I know nothing about blood transfusions and just started looking at it), then the FDA has dropped the ball for two decades and might reasonably use any excuse to make AFFY test Hematide, before it's approved, not relative to Amgen's similar drugs, but relative to placebo with no similar drug administration.Jul 8, 2010. 02:42 PM | 0 Likes |Link to Comment
Here's a little background on this class of drugs: www.fda.gov/ohrms/dock...
Discussed studies appear both clever and annoying, in that they evaluate Epoetin (Epogen/Procrit approved beginning in 1989) and Darbepoetin (Aranesp approved beginning in 2001) only in terms of different dosing, not relative to blood transfusions alone or whatever other treatment predated Epoetin. The obvious objection is: all such studies are pathetically favorable to the drug company, for they all must conclude to take more or less of the given drug.
Moreover they horrendously assume that the differently adverse outcomes result from different targeted blood levels rather than from side effects of the drug. Indeed, persistent findings of higher deaths accompanying higher drug concentrations may simply reflect a drug that's dangerous for reasons irrelevant to the targeted blood level. Aranesp appears to have been approved in 2001 based on its non-inferiority to Epoetin approved in 1989, which appears to have been approved based on flimsy studies of not much. Why in the world does the FDA accept all these studies comparing more or less use of the same drug rather than its use relative to other treatments?
The simple question remains: what are the alternatives to Epogen/Aranesp/Hematide treatment -- just more frequent blood transfusions? -- and what is a solid estimate of $X and $Y above.)Jul 8, 2010. 12:21 PM | 0 Likes |Link to Comment
Looking at this for the first time this morning, because I enjoyed some of your earlier write-ups. Two issues:
1. "This situation poises Hematide to have the long-lasting erythropoietin market in the US essentially cornered." AFFY 8-K filed 6/21/2010 notes "Hematide was dosed once every four weeks while ... darbepoetin was dosed every two weeks," not one week. In itself, is 4-week vs. 2-week dosing a significant advantage?
Moreover: "Aranesp [darbepoetin] is approved for once-monthly dosing for treatment of anemia in pre-dialysis patients in Europe. In the U.S., Amgen is reportedly in the process of seeking approval for once-monthly dosing of Aranesp for treatment of anemia in pre-dialysis patients." (AFFY 10-Q filed 5/6/2010)
2. I stopped reading the AFFY 10-Q filed 5/6/2010 at the following excerpt, because it suggests the class of drugs is inferior to taking nothing in all critical respects except the requirement for blood transfusions, and "The FDA recently announced that it anticipates convening a committee meeting later in 2010 to re-evaluate the use of ESAs...." Consequently I imagine that any bullish case for this class of drugs should quantify their apparent cost benefit vs. blood transfusions along the lines: administering Aranesp [darbepoetin] to 1,000 patients costs $X and saves $Y in blood transfusions. What are your estimates of $X and $Y, and on which facts do you base those estimates?
"In late 2009, Amgen Inc., or Amgen, announced the results of its large, randomized, double-blind, placebo-controlled Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type-2 diabetes (TREAT). In this study, treatment of anemia with Aranesp to a target hemoglobin of 13 g/dL, which is higher than the 10 g/dL - 12 g/dL range approved by the FDA in the current label, reportedly failed to show benefit compared to placebo with regard to composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) and a composite of time to all-cause mortality or chronic renal replacement. In addition, higher rates of stroke were reported amongst patients treated with Aranesp compared to the placebo group. Further, among a subgroup of patients with a history of cancer at baseline, a statistically significant increase in deaths from cancer was observed in the Aranesp treated patients compared to placebo treated patients. However, Aranesp treatment reportedly was associated with a statistically significant reduction in blood transfusions and a modest improvement in patient reported fatigue.
"In January 2010, FDA officials recently published an editorial in the New England Journal of Medicine entitled "Erythropoiesis-Stimul... Agents — Time for a Reevaluation" and announced that it anticipates convening a public advisory committee meeting later this year to evaluate the use of ESAs in the treatment of anemia due to chronic kidney disease. The editorial noted that a number of randomized trials, including TREAT, have attempted to show that using ESAs to raise hemoglobin concentrations to higher targets improves clinical outcomes but rather have suggested the opposite...."
Your bullish case appears to rest on the infrequent dosing advantage of Hematide -- questioned on a quick view of the facts per #1 -- and its general non-inferiority relative to a class of drugs that the above excerpt suggests are dangerous and worthless in all critical respects beyond reducing blood transfusions.
Consequently that key question: administering Aranesp [darbepoetin] to 1,000 patients costs $X and saves $Y in blood transfusions. What are your estimates of $X and $Y, and on which facts do you base those estimates?Jul 8, 2010. 11:00 AM | 1 Like |Link to Comment
First Line Treatment for Obesity – The Holy Grail of Biotech [View instapost]
Where are the logicians? That doesn't mean targeting 2c is long-term safe.May 31, 2010. 06:01 AM | 0 Likes |Link to Comment
Mannkind: Overlooked Biotech With Excellent Prospects (Part I) [View article]
But it appears to do nothing of the sort. The first graph peaks at 60 minutes, whereas TI appears to peak within 15. Scales of the two graphs are even dissimilar. Does anyone actually read the 10K? What am I missing in this graphical comparison?Jul 10, 2008. 02:34 AM | 0 Likes |Link to Comment
87 Comments


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|Woman is the future of man. That means that the world which was once formed in man's image will now be transformed to the image of woman. The more technical and mechanical, cold and metallic it becomes, the more it will need the kind of warmth that only the woman can give it. If we want to save the world, we must adapt to the woman, let ourselves be led by the woman, let ourselves be penetrated by the Ewigweiblich, the eternally feminine!
– Milan Kundera
|Woman is the salvation or the destruction of the family. She carries its destiny in the folds of her mantle.
– Henri-Frederic Amiel
|Woman was created last so she wouldn't have to wait for someone to talk to.
– Vikrant Parsai
|Woman's honor is nice as ermine; it will not bear a soil.
– John Dryden
|Woman's influence is powerful, especially when she wants something.
– Josh Billings
|Woman, the more careful she is about her face, the more careless about her house.
– Ben Jonson
|Women and cats do as they damned well please, and men and dogs had best learn to live with it.
– Alan Holbrook
|Women are a sisterhood. They make common cause in behalf of the sex; and, indeed, this is natural enough, when we consider the vast power that the law gives us over them.
– William Cobbett
|Women are always being tested...but ultimately, each of us has to define who we are individually and then do the very best job we can to grow into it.
– Hillary Rodham Clinton
|Women are at last becoming persons first and wives second, and that is as it should be.
– May Sarton
|Women are cursed, and men are the proof.
– Rosanne Barr
|Women are ever in extremes, they are either better or worse than men.
– La Bruy?re
|Women are ever masters when they like, And cozen with their kindness; they have spells Superior to the wand of the magicians; And from their lips the words of wisdom fall, Like softest music on the listening ear.
– Firdausi
|Women are like Records.... chasing them always leads to dissapointment.
– Siddharth Astir
|Women are like teabags. You dont know how strong they are until you put them in hot water.
– Eleanor Roosevelt
|Women are the fulfilled sex. Through our children we are able to produce our own immortality, so we lack that divine restlessness which sends men charging off in pursuit of fortune or fame or an imagined Utopia. That is why we number so few geniuses among us. The wholesome oyster wears no pearl, the healthy whale no ambergris, and as long as we can keep on adding to the race, we harbor a sort of health within ourselves.
– Phyllis McGinley
|Women are the glue that hold our day-to-day world together.
– Anna Quindlen
|women are "unsuited by nature for all scientific mechanical employment".
– Augustus Granville
|Women can form a friendship with a man very well but to preserve it--to that end a slight physical antipathy must probably help.
– George Jean Nathan
|Women dress alike all over the world: they dress to be annoying to other women.
– Elsa Schiaparelli
|Women have been trained to speak softly and carry a lipstick. Those days are over.
– Bella Abzug
|Women have more strengths in their looks than we have in our laws, and more power in their tears than we have by our arguments.
– Saville
|Women have more to offer this world than just a fallopian tube. Nothing is going to change until you quit looking at us as just sperm receptacles.
– Barbara Hall
|Women have served all these centuries as looking-glasses possessing the magic and delicious power of reflecting the figure of a man at twice its natural size.
– Virginia Woolf
|Women have the right to work wherever they want, as long as they have the dinner ready when you get home
– John Wayne

subset: commoncrawl


text:
Editor's pick
MK to Terrorist Widow: What About the 25 Orphans?
Inside Israel
Arutz 7 Most Read Stories
Syrian Hackers Wish a 'Happy Thanksgiving'
Technology & Health
ISIS Blocks Mobile Phones in Mosul
Middle East
Ya'alon Admits to Discrimination Against Jews
Inside Israel
Daily Israel Report
Show More
It's OK to Spin for Terrorists, but Not the World Cup
Ronn Torossian
Pollard and the US Government: A Polity of Amorality
Barouch Levy
A Western Tourist Hasn't a Chance in a Persian Bazaar
Dr. Mordechai Kedar
Israeli Sovereignty on Temple Mount: Slip Sliding Away
MK Moshe Feiglin
Show More
Missouri vs. Misery
Rav N Kahana
Covenant & Conversation for Vayetze
Rabbi J. Sacks
The Temple Institute on Vayetze
Rav C.Richman
On the Parsha: Confronting Laban or Not?
Rav Gordimer
On the Parsha: Failure is Our Only Option
Rabbi E Safran
On the Parsha: Putting Children First
Rabbi Gurkow
News Brief
8/2/2012, Av 14, 5772
NJ Gov. Imposes New Iran Sanctions
NJ Gov. Christie signed into law new sanctions against Iran that prohibit public contracts with any company or person who invests in Iran.
Full Story


text:
Event Gallery
3.2.1 (last update on Oct 15, 2014)
GPLv2 or later
Free Download
28 March 2013
- Yes
Event Gallery is an easy to use gallery component for Joomla. It supports adaptive, flexible and responsive layouts and provides a unique way of presenting images. If presenting is not enough enable the cart! Let users browse through your images and buy them.
Event Gallery 3 adds a full cart&checkout process to the gallery.
Just one word to the used terminology. Because I initially wanted to display images for events, the used terms are chosen accordingly. Today an event is more a folder containing images.
Main Features
- Joomla 2.5 / 3.2 / 3.3 compatible
- Supports responsive layouts
- Includes Google Picasa Webalbums and local stored images
- ICC profile support
- Image processing like sharpening
- Password / User Group protected folders
- Five configurable ways to display images
- Comments for images
- Integrated Lightbox
- Easy image management using the Joomla back end
- Supports FTP uploads for mass data processing
- Multiple file upload with modern browsers
- Cart&Checkout for images
- swipe gesture support for the lightbox
- Social Sharing (Facebook, Google+, Twitter, Direct Download, Pinterest)
- Watermarks
Since the install package is pretty large make sure your upload limit is high enough. If not just the download link to install it using the Joomla Extension Manager.
If you encounter any issues please let me know. Usually they can be solved in a couple of hours or even faster. Please check the requirement section in the manual to sort out possible issues as soon as possible.
Also the fact that you can sell photos with the Cart&Checkout feature make it irresistible. The support is great and fast too. I had a minor issue with Facebook share function and Sven not only helped me but did even more from what i requested.
Great extension, very straight forward to use with no bugs at all, such an elegant design and excellent support, I totally recommend it.
Reviews: 2
The best gallery for me :)
Installation is pretty straight forward and easy to do, configuration is just as easy. Had to contact the developer with a few questions and was able to not only get a reply quickly but was able to debug a few things that weren't part of the component itself but were core features that made modifications to the templates.
Reviews: 8
But the thing that really makes it stand out is the support Sven gives, excellent!! A role model for other developers :-)
Page 2 of 6


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This data was produced by OpenAustralia from a variety of sources.
Ms Anna Burke MP
- Australian Labor Party Representative for Chisholm
- Changed party from Speaker on 5 Aug 2013; from Deputy-Speaker on 9 Oct 2012; from Australian Labor Party on 11 Feb 2008
- Entered House of Representatives on 3 October 1998 — Federal election
- Email me whenever Ms Anna Burke speaks (no more than once per day)
Most recent appearances in parliament
- Matters of Public Importance: Budget (30 Oct 2014)
"I am very pleased to be speaking on this MPI today, because I cannot even begin to count the number of times I have said, 'I don't want to be part of the first generation in history that leaves our planet and environment in a worse state for our children than when we found it.' But sadly, this government is determined to make sure that I am part of the first generation to leave our next..."
- Adjournment: Chisholm Electorate: Ashwood Reserve (30 Oct 2014)
"If you are going to run for any level of government, be it state, local or federal, you should have some connectivity with the community you are seeking to represent. If you do not, you should at least get to know them. It is with a feeling of great tragedy, almost comedy, that I rise today to speak about Ashwood Reserve in my electorate. I am not going to have a go at the Liberal candidate..."
- Statements by Members: Chisholm Electorate: Patronato Office (29 Oct 2014)
"Today I have been contacted by the Patronato office in Oakleigh, in my electorate, by Sebastian Rustica, who has been doing an amazing job since 1980. Patronato provides free advice on Italian social security matters to members of the Italian community and is supported by the Italian government. The Patronato office in Oakleigh has been assisting the Italian community with queries around..."
More of Ms Anna Burke's recent appearances
Please note that numbers do not measure quality. Also, Representatives may do other things not currently covered by this site. (More about this)
- Has spoken in 49 debates in the last year — below average amongst Representatives.
- People have made 1 comment on this Representative's speeches — average amongst Representatives.
- This Representative's speeches are understandable to an average 15–16 year old, going by the Flesch-Kincaid Grade Level score.
- 22 people are tracking whenever this Representative speaks — email me whenever Ms Anna Burke speaks.
- Has used three-word alliterative phrases (e.g. "she sells seashells") 534 times in debates — well above average amongst Representatives. (Why is this here?)


text:
Tel: (316)838-1243
Word of Life Traditional School was founded in 1999 in Wichita, Kansas.
Our students graduate with accredited diplomas from the state of Kansas which makes getting into college a much smoother experience.
Our elementary students test 1 to 2 years higher on average then public schools.
WOLTS has higher standards academically than public schools.
Word of Life Traditional School has tested with overall improvement on the Kansas State Tests two years in a row.
Our four year olds in K-4 are reading by Christmas and our High School Students have duel credits available through Friends University.
We strive to provide an exciting, full, excellent, competitive sports program.
School Overview
|Religious Affiliation
|Grades Offered
|Grades Prekindergarten - 12
Student Body
|Total Students
|150 students
|Student Body Type
|% Students of Color
State avg.: 17%
|Students by Grade
Academics and Faculty
|Total Classroom Teachers
|11 teachers
|Student : Teacher Ratio
National avg.: 13:1
Nearby Schools:
All Schools | High Schools | Elementary Schools | Preschools | Public Schools
Show me:
- School Location Miles Students Grades
WichitaRiverlawn Christian Academy
4243 N Meridian Avenue
Wichita, KS, 67204
(316)832-0544(Christian)0.5 mi | 32 students | Gr. PK-6
WichitaSt Jude Catholic School
3030 N Amidon Ave
Wichita, KS, 67204
(316)838-0800(Roman Catholic)1.1 mi | 202 students | Gr. PK-8
WichitaSt. Patrick Catholic School
2023 N Arkansas Ave
Wichita, KS, 67203
(316)262-4071(Roman Catholic)2.7 mi | 173 students | Gr. K-9
WichitaThree Angels Seventh-day Adventist School
4558 N Hydraulic St
Wichita, KS, 67219
(316)832-1010(Seventh-Day Adventist)3.1 mi | 12 students | Gr. KG-7
WichitaThurman KinderCare
8722 Thurman Street
Wichita, KS, 67212
(316)721-0168Daycare / Preschool4.8 mi | n/a students | Gr. NS-PK
School Reviews
Area Statistics
Recent Articles
Updated October 26, 2014
What do you do when you are dissatisfied with your local public schools? Homeschool your children? Send them to private school? Let's look at your options.
Your religion matters to you. You want your child to attend a school which will combine academics and religious education. Here is an overview of what is available together with some links to denominational web sites.
Add things up and you'll quickly find the answer- math is crucial both in academics and the real world. By following these strategies and following personal training programs, students can uncover their weaknesses and conquer math.


text:
Guidance Note: Gender and Law - Temporary Special Measures to Promote Gender Equality
Nearly all developing member countries (DMCs) of the Asian Development Bank (ADB) have adopted laws and policies to promote gender equality. However, there is often a reluctance to operationalize these, and/or a lack of knowledge of the appropriate mechanisms. This publication presents a case for the use of temporary special measures as a mechanism to correct gender imbalances and accelerate progress toward gender equality goals. Temporary special measures are a set of proactive measures that include gender-inclusive design features, quotas, and targets in ADB projects. This note is designed to increase understanding of the legal obligations of DMCs to achieve gender equality, and what this means for designing and implementing ADB projects.
- Introduction
- Is gender equality a legal obligation?
- Why is CEDAW important?
- How does CEDAW define TSM?
- Why is substantive gender equality relevant to CEDAW and TSM?
- What is the difference between not discriminating on the grounds of sex or gender, and actively promoting gender equality?
- What is the legal basis for TSM?
- How temporary are TSM?
- What is the consequence of not complying with CEDAW or TSM or domestic gender equality laws for DMCs?
- Who is responsible for promoting gender equality in ADB-financed projects?
- Who is responsible for promoting gender equality in ADB-financed projects?
- Is it necessary to put TSM in all ADB-financed projects?
- Does ADB need to address gender equality when there is no overt discrimination against women?
- Is ADB's GAD policy subject to review by ADB's Accountability Mechanism?
- What is the legal basis for ADB-DMC dialogue on positive gender design measures or TSM?


text:
In The Heat of the Moment
...there was one post (very immature and venting) related to this. If I recall nobody even commented as it was so *un Ron Paul*. If they can find it the Mods might want to delete it.
In retrospect, I wish I had commented on it.
It was just venting right after the event and every post on the DP certainly does not reflect Ron Paul supporters.
I hope all DP posters will read this and realize that such venting reflects poorly on all of us and would never be condoned by anyone on this blog. It could have even been a *plant* to later capitalize on. I hope nothing was posted like this anywhere else.
Just ALWAYS remember...What Would Ron Paul Do...and act accordingly. Please.
- Login to post comments


text:
Tag: program
Tips on removing apps from the Sync Services database
If you've ever installed an app that can take advantage of .Mac syncing services and then stopped using it or removed it for one reason or another, you might have noticed that its listing in the .Mac System Preferences pane still lingers. This could be a nuisance to neat-freaks, but it could also ca...
MailTags 1.2.1 available, 1.3 to feature IMAP syncing
Dave Caolo posted about MailTags last August, but in case you're unfamiliar: MailTags is a fantastic plugin for Mail.app that allows you to both tag your messages and create iCal todos right from within Mail. MailTags' abilities go far beyond simply adding a few keywords though; you can also set pro...
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Software Updatesmore updates
- Yahoo Mail improves email inbox searching with new filtering options
- Ember for Mac gains 'hugely-requested' screen recording feature
- Spotify update adds equalizer, refreshed Artist page and more
- Fantastical 2.1 for iOS adds new snooze, search and notification features
- ExpanDrive 4, more services and faster sync
- Apple adds iTunes Extras to Apple TV


text:
Dishonoured is being developed by Arkane Studios and published by Bethesda Softworks.
Originally Posted by Bauul
It looks like on the most exciting new IPs in ages, a combination of Half-Life, Bioshock, Deus Ex and Thief. What's there not to like?
Isn't it rated PEGI 18? 16 year olds shouldn't be learning anything from it! :pOriginally Posted by Chicken76
Doesn't it bother anyone that the plot is so similar to that of The Witcher 2?
Oh, and "Revenge solves everything"?! Is this what 16-year-olds are supposed to learn from a computer game?
Far Cry 4 Review
25th November 2014
Assassin's Creed: Unity Review
21st November 2014
Call of Duty: Advanced Warfare Review
12th November 2014


text:
1-10 of 80 properties for sale found
£1,300,000 Guide Price
Guide Price £1,300,000
4 bedroom detached house for sale The Fairway, Upminster
This imposing 1930s family home of quality and character is offered for sale with vacant possession and presents an exceptional real estate opportunity. The property sits back off the road with considerable frontage and kerb appeal and has a large South facing rear garden. There is much scop (con... More details ›
4 bedroom cottage for sale UPMINSTER
AT THE 19TH HOLE A fantastic home boasting spacious rooms and the perfect setting, the property at The Fairway is a fabulous family house with endless potential. More details ›
5 bedroom detached house for sale Engayne Gardens,Upminster,RM14
A substantial detached house located in one of Upminster¿s premier turnings north of the town centre offering reception hall, 3 receptions, fitted kitchen/family room, utility, cloakroom, sauna/shower, 4 bedrooms (1 ensuite), bath/wc, central heating, double glazing, own drive, garage, 200ft garden, More details ›
3 bedroom detached house for sale Fen Lane, North Ockendon, Upminster, RM14
Benefiting from grounds extending to approximately 5 acres (subject to land survey) and located within this sought after and highly desirable semi rural location yet offering good access for all local amenities is this fully detached three/four bedroom family house originally built as (contd...) More details ›
4 bedroom detached house for sale Fen Lane, North Ockendon, Upminster, Essex, RM14
Detached property on a plot exceeding 4 Acres, views over open countryside, four bedrooms, double garage. EPC F. More details ›
3 bedroom detached house for sale Corner Farm Cottage, Fen Lane, North Ockendon, Upminster
Located in a semi-rural position, is this detached three/four bedroom character property which benefits from an additional lawned field of approximately four and a half acres (to be confirmed by land survey). (contd...) More details ›
5 bedroom semi-detached house for sale Upminster
Situated on the north side of town in a most prestigious location with a westerly rear aspect this Five Bedroom Semi-Detached Family House, offers generous living accommodation, extensive double glazing, gch, mature rear garden backing golf course and with Carport leading to Garage via own driveway. More details ›
£930,000 Guide Price
Guide Price £930,000
4 bedroom detached house for sale Bulphan
With 5.75 acres - An excellent premises with a highly appointed four double bedroom (two en-suite) main house More details ›
£900,000 Offers in Excess of
Offers in Excess of £900,000
5 bedroom semi-detached house for sale Upminster
Situated on the north side of town in one of Upminster's most prestigious road is this impressive Five Bedroom Semi-Detached House, benefiting from good sized and well presented living accommodation, superb rear garden 200' approx. and own drive to garage with further parking to front. Recommended. More details ›
£900,000 Offers in Excess of
Offers in Excess of £900,000
5 bedroom detached house for sale The Fairway, Upminster, Essex, RM14
Premiere turning, north side of Upminster, walking distance to station, town centreand high-achieving schools for all ages. EPC C More details ›
Thank you.
Your information has been sent to 0 out of 16 agents who have property to sell in the area you specified.


text:
The Spring Dairy Expo at the Ohio Expo Center will feature an American Dairy Association & Dairy Council Mid East barbecue and the PDCA Judging Conference.
One of the projects the Ohio Bicentennial Commission is developing is a book that will be titled "200 Years, 200 Women: Ohio's First and Finest."
Ohio regulations for burning debris outdoors differ between suburban and rural areas
Whether they encouraged a famous pair of brothers to take flight or boldly challenged slavery, Ohio women have many stories waiting to be discovered.
Lawsuits have been filed against certain manufacturers of vitamins, alleging a long-running international conspiracy to fix, raise and maintain inflated prices of certain bulk vitamins and vitamin products.
Historic Roscoe Village will be hosting its own version of the popular Antique Road Show April 4 with appraisals by Sam Schnaidt.
The Canton Museum of Art's 10th annual Stark County High School Art exhibition will open March 25, featuring original two- and three-dimensional works by area high school students.
Sometimes people are not as sensitive as they could be when coworkers are experiencing grief, says a University of Illinois Extension educator in family life.
Penn State professor of Family and youth resiliency has produced a series of booklets on Making Youth Sports a Positive Experience.
A coalition of governors say a more effective conservation program would help combat suburban sprawl, protect wildlife habitat, and help reduce air and water pollution.
Laws relating to juvenile crime have risen since the mid-1990s because of public outcry, fear, and concern over juvenile violence.
A deluxe edition of "The Pennyroyal Caxton Bible," designed and illustrated by Barry Moser highlights exhibit in Special Collections Library.
The late Clayton Oyler of Union Township and Henry Whitehead from the Granville area were recently recognized as 2001 inductees.
Part six our series discusses the beginnings of a successful marriage.
In recent weeks, USDA has stepped up measures to guard against foot-and-mouth disease entering the United States.
A farm is not a farm without cattle, or so John Beese thought when he went looking for a breed to bring home in the late 1980s.
U.S. livestock producers need to be on the alert and take precautions to keep the disease at bay. It could happen here.
Now is a window of real opportunity for the ethanol industry to take its place in the national energy mix, according to Eric Vaughn, president and chief operating officer of Renewable Fuels Association, the national trade association for the domestic ethanol industry, who spoke to Ohio Farm Bureau leaders visiting Washington.
Author Allan May will discuss organized crime at March 21 Warren library talk.
Sen. George Voinovich said what the Ohio Farm Bureau leaders wanted to hear when he met with them in Washington. He left them pleased if not satisfied.


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The Waring food and beverage blender features a commercially rated motor for faster blending, plus the classic waterfall base and cloverleaf carafe look great in any kitchen. classic waterfall base professionally rated heavy-duty motor 550 peak watts simple 2-speed operation with toggle switch large 40-ounce glass cloverleaf carafe has imperial and metric graduations Metal/glass. Measures 7x8x15"H. Hand wash carafe. Wipe base clean. Assembled in America of imported parts.
Waring Food & Beverage Blender $175.83 $117.20
Makes smoothies, bar drinks, hummus, whipped cream, meringues and more with this sleek inverted blender. The unique inverted carafe design maximizes the flow of ingredients for superior results. variable-speed control dial operates from 1,000-20,000 RPMS pulse override speed 10 operates at 23,000 RPMS stainless steel drive and coupling gourmet recipe book included 56-ounce BPA-free copolyester carafe 1200 watts. Stainless steel with copolyester carafe. Measures 8½x8½x18"H. Lid and carafe are dishwasher safe. Made in America.
Waring 1.75 Horsepower Inverted Blender $504.03 $351.64
Innovative inverted blender jar optimizes the flow of ingredients for exceptional smoothies, bar drinks, sauces and more. Innovative inverted blender jar optimizes the flow of ingredients for exceptional results. Blender expertly mixes bar drinks, hummus, whipped cream, egg whites, meringues and more. Powerful efficiency with 1200 watts, 1.75 horsepower. 56-oz. capacity inverted copolymer carafe with trademark cloverleaf design. Variable speed control dial from 1,000-20,000 RPM. Pulse button for bursts of quick blending power at 23,000 RPM. Stainless-steel drive, coupling and cutting blades. Die-cast waterfall base. Sturdy pouring handle. Blue LED operating lights. Nonslip rubber feet for steady operation. All parts in contact with food are BPA-free. 2-oz. measuring lid and carafe are dishwasher-safe. Includes cleaning tool and gourmet recipe book. 5-year limited warranty
Waring Inverted Blender, MBB1000 $644.69
Soda fountain style drink mixer serves up rich and creamy milkshakes, smoothies, cocktails and more. Classic soda fountain style mixer with retro styling. Efficiently whips up creamy milkshakes, malts, smoothies, cocktails, whipping cream, pancake batter, frothy eggs and more. Heavy-duty, 2-speed motor with chrome-plated cover. 28 oz. stainless-steel malt cup. Automatic startstop and single spindle convenience. Sturdy die-cast metal base. Easy cleanup with soapy water. Includes instruction book with recipes. 5-year limited warranty
Waring Drink Mixer $363.37
Whip up everything from soups, smoothies, sauces or desserts in seconds. Waring Pro's best-selling, commercially-rated blender creates a vortex action for faster, thorough blending. Heavy-duty 550-watt motor features professional-quality, self-cleaning stainless-steel blade assembly. Blend smoothies, sauces, puree or whip up desserts and toppings. User-friendly two-speed, toggle-switch operation for quick, efficient operation. The 40-ounce glass jar with sure-fitting lid features trademark cloverleaf design to pour from any angle. Classic waterfall base is the signature design of Waring Pro's high-performance blenders. Instruction booklet with recipes. Waring Pro is renown as an innovator in professional-quality kitchen appliances for more than 60 years
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generic Ranitidine Tablets For Animal Use 300 mg/250 ct (Rx Pet Meds)
Ranitidine Tablets may be used to reduce stomach acid production in horses, dogs and cats. Ranitidine may be used to aid in the treatment of existing ulcers and help prevent ulcer development. Ranitidine Tablets may be used in the treatment... of reflux... Read More
Your child can sing along to favorite songs with the Sofia the First Disney Sing-Along Boombox. It features fun phrases from the m...ovie and includes a real microphone that actually works. Connect it to any MP3 player and let your child have fun. A... Read More
This Disney Table Lamp features a polka dot pattern, a heart-shaped pull-string switch and a metal base. With its Minnie Mouse des...ign, this baby table lamp will be a sweet addition to a child's bedroom. Cute and compact, this lamp will fit a variety of... Read More
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text:
Bun B - Fire
Artist: Bun B
Featuring: Rick Ross, 2 Chainz
Producer: Blackout Movement
Album: Trill O.G. "The Epilogue"
Avg Rating: 3.8 ( 11 votes )
When Bun B is involved with a cut, you just know it's gonna be straight Fire. The newly-released lead single off his fourth solo album is, of course, no exception to the rule. Here, Blackout Movement's ominous, string-laced street boardwork backs the UGK alumnus as he turns up the heat on his rivals in the rap game. In addition to Bun's own scorching bars, the record boasts white-hot guest 16s from Def Jam hitmaker 2 Chainz and MMG capo Rick Ross. (Unfortunately, the latter's appearance serves to emphasize the beat's resemblance to J.U.S.T.I.C.E. League's I'm Not a Star production.) Kingston, Jamaica's Serani lends a touch of dancehall flavor to the record's hook. If this whip-ready single's left your speakers sizzling, you can watch our pages for more fresh records leading up to the November 12, release of Bun B's currently-untitled senior set.
Bun BRick Ross2 Chainz HitmakerStreet Banger
Written by richard on 09/11/13
Submit your Rating
First DJ Booth Appearance:
"They Don't Wanna Play ft. Bun B & Bad Seed" (2007)
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Bloomsburg University is a great place to be you!
Bloomsburg University is a great place to be you!
Unleashing the you at BU
"Don't panic. Grad school is the perfect place to make mistakes. You're surrounded by helping professionals who want nothing more than to see you succeed! If everything hasn't fallen into place quite yet, don't worry too much. It will."
— Alyssa Meyers, pursuing Counseling and College Student Affairs degree
A digital twist to language learning
Bloomsburg University is a place in which students gain much more than knowledge applicable to their future goals; they are also are provided with opportunities to apply that knowledge to real-world scenarios.
One student, Andy Rector, a digital forensics major and Chinese minor from Mifflinburg, has used the opportunities that BU has presented him with to gain new and exciting experiences on and off campus. Although minoring in Chinese was not a path that Rector had foreseen, he quickly discovered the benefits of writing and reading this particular language.
"China turns out to be one of our biggest competitors in the cyber world," Rector says. "Knowing something about Chinese and being able to read and write (Chinese), in my mind, is a great way to interview for a job. It's certainly a point of interest."
Huskies compete at Keystone Classic
Bloomsburg University's wrestling team competed at the Keystone Classic in Philadelphia, led by Tanner Cahill who finished sixth at 141 pounds. In the consolation round he beat Paul Kirchner of Rider by fall in 41 seconds, then beat Travis Schaffer of Pitt, 12-8. In the consolation semifinals he lost by fall to Jameson Oster of Northwestern; then fell to Mike Longo of Appalachina State, 5-1, in the fifth place match. At 133 pounds Andy Schutz went 2-2 winning by major decision and fall, while at 149 pounds Kevin Laubach went 3-2 on the day winning twice by decision and once by fall. Bloomsburg returns to action Saturday, Dec. 6, when it hosts the PSAC Championships starting at 10 a.m.


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It's a honey badger thing you wouldn't understand is a funny,humorous, meme about fearless honey badger who has a don't care attitude.A great gift for an animal lover with a sense of humor.
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Sharjah Cricket Association Stadium, Sharjah ,11/26/2014, 11:30 (IST)
Zahur Ahmed Chowdhury Stadium, Chittagong ,11/23/2014, 12:00 (IST)
Bangladesh beat Zimbabwe by 68 runs
P Sara Oval, Colombo ,11/24/2014, 10:00 (IST)
Hong Kong beat Nepal by 2 wickets
Shere Bangla National Stadium, Mirpur ,11/26/2014, 12:00 (IST)
Titanic is a 1997 American disaster/romantic/drama film directed, written, co-produced, and co-edited by James Cameron about the sinking of the RMS Titanic. It stars Leonardo DiCaprio as Jack Dawson and Kate Winslet as Rose DeWitt Bukater, two members of different social classes who fall in love aboard the ill-fated maiden voyage of the ship. The main characters and the central love story are fictional, but some characters (such as members of the ships passengers and crew) are based on historical figures. Gloria Stuart portrays the elderly Rose, who narrates the film in a modern day framing device, and Billy Zane stars as Cal Hockley, the overbearing fianc� of Roses younger self. Source: Wikipedia
Which of these actors have carried the "Bald" look in Style?


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Astronomy Software
Showing page 1 of 1.
Parallel Iterative Deconvolution
Parallel Iterative Deconvolution is a multithreaded ImageJ plugin for iterative image deblurring.33 weekly downloads
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My Lunar Calendar
This is MyCalendar object which extends GregorianCalendar object, user can get lunar information by reading related attributes.2 weekly downloads
Universal Worker Service
Universal Worker Service is a pattern for asynchronous web-services that is used in the VIrtual Observatory field.1 weekly downloads
Eclipse for ACS Module Development
A very basic plugin for Eclipse for developing ACS modules.0 weekly downloads


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text:
Growth in Spain Threatens a Jewel of Medieval Islam
Pools of mercury could be shaken to spray beams of reflected sunlight across marble walls and ceilings of gold, according to contemporary records.
Doors carved of ivory and ebony led to sprawling gardens full of exotic animals and sculptures made of amber and pearls.
"Travelers from distant lands, men of all ranks and professions in life, following various religions, princes, ambassadors, merchants, pilgrims, theologians, and poets all agreed that they had never seen in the course of their travels anything that could be compared to it," wrote the 19th-century historian Stanley Lane-Poole in his book "The Story of the Moors in Spain."
Archaeologists are more hesitant, saying that while many of those marvels may have existed, physical evidence of them has yet to be found. But they, too, are full of superlatives.
"This was the largest city ever built from scratch in Western Europe," covering nearly 280 acres, Antonio Vallejo, the chief archaeologist here, said in an interview. "Most large Western cities grow over time. This was built in a single effort, from a single design."
Now, less than a hundred years after its ruins were identified and its location resurrected on modern maps, a threat has emerged. Construction companies are putting up houses on the site of the city, 90 percent of which remains unexcavated.
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Rivera announces he'll retire after season
Updated On: Mar 09 2013 05:19:06 PM PST
Rivera made the announcement at a news conference at George M. Steinbrenner Field in Tampa, Fla.
A likely first-ballot Hall-of-Famer, the 43-year-old Rivera is a 12-time All-Star and played on five World Series championship teams. The career saves leader with 608, Rivera has only blown 39 saves in his career, and posted a 2.21 ERA with 1,119 strikeouts in 1,219 2/3 innings.
"After this year, I will be retiring," he said with his family at his side.
"It's not too easy when you come to a decision like this. After this year, I will be retired. ... Now you're hearing it from me. It's official now."
Rivera said he would have retired after the 2012 season, but sustained a season-ending torn ACL in May, and wanted to exit on his own terms.
"I didn't want to leave like that," he said. "I felt like I wanted to give everything."
He is expected to appear in relief Saturday for the first time since his injury.
"He is irreplaceable," general manager Brian Cashman said. "He is the greatest of all-time. I've known him since he has been in the minor leagues. He has never changed once. You have seen a lot of players get a lot of money and a lot of notoriety and become famous and they change over time. He hasn't changed a bit."
The right-hander has also logged 141 postseason innings, and posted 42 saves in 47 chances with a 0.70 ERA.
Rivera hopes to add to his playoff credentials.
"The last game I hope will be throwing the last pitch in the World Series," he said. "Winning the World Series, that would be my ambition."
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UCSC demonstrators end building occupation
San Benito County Supervisor Rivas: Courts will uphold Measure J


text: We have stayed here now 4 times and I plan to return. This is the perfect escape to get away from the hectic city and fast paced life. Feels like you are 100's of miles away and in reality only minutes away from home. We found the atmosphere to be very relaxing and Jim is absolutely the "BEST!!" All meals... More


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Winnipeg Free Press - PRINT EDITION
Boss's demands for rides driving employee crazy
Dear Miss Lonelyhearts: I'm a single parent. My kids are the most important people in my life. I have a good job and do my best to provide everything for them. Our lives are very busy, but we do find time to be together. The problem is that lately my boss is making it very difficult for me to keep my priorities straight.
She has me driving her to and from work and to meetings. She never contributes to any costs. I have tried on many occasions to say no in different ways, but somehow I still end up being her driver. How can I get out of this without jeopardizing my job? Being her chauffeur is in no way a part of my job description. -- Desperate, Winnipeg
Dear Desperate: She has found herself a free chauffeur with a warm car who always says yes. If you work for a large company, or the government, this is a problem that would be best solved with the help of human resources, as your job would then be protected. Where is your boss's car? Does she not have one?
"My life has gotten very busy with kids' activities now that they are older. I like to help you with work duties, but driving you is one way I just can't help," should be your new mantra. "If I drive you, I leave my kids stranded and unsafe." If you work for a small company and there is no union or any kind of protection, you may have to invent an untruth about what you need to do in the mornings with your kids, as you are a single parent. This is a rather unusual problem, although self-centred people are common. If readers have any experience with this or ideas to help, please write in and share them.
Dear Miss Lonelyhearts: I'm a 35-year-old woman and I've got a question for some women my age. Where do you get off treating "nice guy" friends like crap when you're in relationships with losers? I know this woman who works while her boyfriend stays home, sleeps until lunch, does nothing all day and can't even make himself anything to eat until she comes home. She brags about him like he's a god. Her nice guy friend works his ass off, and she depends on him for money.
I know another woman in the same situation with a different nice guy and she brags to her girlfriend that he's her "personal banking machine." Maybe these "nice guys" have feelings, too! I hope you witches read this and actually think about it. -- Fed Up With You Girls, Winnipeg
Dear Fed Up: Yes, these women are nasty, particularly the one who calls her friend a "personal banking machine." So what can you do about it? How about telling off these female users when you get a chance? Stand up for what you believe a decent woman should be. As long as no one says anything, these women don't get any wakeup calls.
Also, guys have a responsibility to themselves to disallow people from using them. For some odd reason, they're hanging around women who have boyfriends doing nothing on the couch. These "nice guys" are enabling the relationships to go along happily by giving the women money whenever they need it. Are they waiting for the relationships with the couch potatoes to end instead of looking for their own women to love? Do a spring housecleaning -- drop the users and enablers from your circles.
Please send your questions or comments c/o email@example.com or mail letters to Miss Lonelyhearts c/o Winnipeg Free Press, 1355 Mountain Ave., Winnipeg, MB, R2X 3B6
Republished from the Winnipeg Free Press print edition March 18, 2014 C4
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Originally written on Ring Side News | Last updated 11/20/14
- The talk about Paul Heyman and CM Punk mocking Jerry Lawler's heart attack on RAW continues on Twitter with several wrestlers weighing in such as Steve Austin and Chris Jericho. The Baltimore Sun's Arda Ocal spoke with some Superstars and got their reactions: Steve Austin: "I believe in pushing the envelope in an aggressive fashion. But when a guy damn near dies at ringside, let it go. You look at all the contributions Jerry Lawler has made in this business: from a work standpoint, a promo standpoint and then as a broadcaster. I think that's pushing the envelope in the wrong direction. There's better ways to go get real heat than that." Chris Jericho: "I think it was pretty obvious, don't you? I kind of expected it. Punk's promo was awesome. It's wrestling so you knew it would end up as an angle sooner or later. I got the same complaints when I did the alcoholic angle (earlier this year with CM Punk). It would be like being mad at "Breaking Bad" because the dad was a drug addict or something. It's just a TV show, after all." Lance Storm: "Thought it was poor. Both he and Punk are capable to get real heat, no need to sink so low. Also thought it was out of character for Punk so it hurt. Punk is about Best in World and himself. Why bother joking about heart attack it goes nowhere. Interuption was okay and in character. Fake heart attack was cheap and pointless." WWE's Matt Striker wrote the following on Twitter: "Watching Paul Heyman makes me feel like I need hand sanitizer" Heyman replied: "I think @Matt_Striker's comment about me is low brow, uncalled for and insensitive. MY FEELINGS ARE HURT!!! cc: @CMPunk" When Will Heyman Bring Lesnar Back?, Vince's Reaction to the Heart Attack Angle, More...
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27 results for "welker"
The Molly Diaries: Wes Welker's Day at the RacesJason Concepcion
"Christ, man ...; Jesus ...; you ever seen a horse like this before?" Wes Welker asked the stable boys, and they nodded, because indeed they had. Welker was sweating profusely and staring at a saddle perched on a...Blog | September 03, 2014
About Last Night: You've Been Kershaw'dSpike Friedman
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The ShowstoppersBill Barnwell
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About Last Night: Cheery O'sSpike Friedman
In case you were busy taking a ride into the danger zone with Wes Welker, here are the top six stories you missed in sports on Monday: Orioles outfielder Adam Jones smashed two home runs as Baltimore opened up a four-game advantage in the AL East...Blog | July 22, 2014
Week 12 Fantasy Football Preview: The Other GuysMatt Borcas
Welcome to Week 12, where Brady-Manning XIV is far from the only riveting QB showdown on the docket. We've also got Tolzien-Ponder, McGloin-Fitzpatrick, and Henne-Keenum, which we'll be breaking down in great detail a little bit later, because I know...Blog | November 21, 2013
Pass Atlas: How Wes Welker Is Making Peyton Manning Even BetterKirk Goldsberry
Peyton Manning had the best passing performance of Week 1. This is not really up for debate. He threw for seven touchdowns, tying an NFL record, along with 462 passing yards. And despite throwing the ball 42 times, he threw no interceptions. Manning ...Blog | September 12, 2013
Fantasy Football Week 1 Waiver Wire: Don't Let Peyton Manning Poi...Matt Borcas
If it's possible for someone who shares a bed with one of the world's leading supermodels to have a bad night, Tom Brady's Thursday must've sucked. I assume Brady howled like a werewolf at the sight of erstwhile blood brother Wes Welker snagging two ...Blog | September 10, 2013
The Broncos and Ravens and Some Predictions for Football's Welcom...Andrew Sharp
We made it. We did it. Bill Simmons almost killed Robert Mays with the warning series. Bill Barnwell wrote 200,000 words every day and didn't even seem to blink, which is maybe more concerning. There was baseball that happened. Brian Phillips t...Blog | September 05, 2013
Fantasy Football Preview 2013: Wide Receiver RankingsMatt Borcas
It's that time of year — when snakes, auctions, ADPs, keepers, and sleepers start to rule our football hearts and minds. This season, last year's Fantasy Island contest winner, Matt Borcas, will be providing some fantasy insight, starting with ...Blog | August 23, 2013
NFL Preview Podcast Series: Broncos and ChiefsGrantland Network
Bill Barnwell and Robert Mays continue their NFL Preview Podcast Series with the Denver Broncos and Kansas City Chiefs. Previous Installments of NFL Preview Podcast Series Bears and Lions Packers and Vikings Texans and Titans Co...Blog | August 22, 2013
Fantasy Football Preview 2013: Preseason Recap, Week 1Matt Borcas
It's that time of year — when snakes, auctions, ADPs, keepers, and sleepers start to rule our football hearts and minds. This season, last year's Fantasy Island contest winner, Matt Borcas, will be providing some fantasy insight, starting with ...Blog | August 14, 2013
28-Day NFL Warning: The Transitions of DeMarcus Ware and Wes Welk...Robert Mays
What's that? You were wondering exactly how many days until the start of the NFL season? Well, you're in luck! We here at the Triangle are set to spend the next month providing a daily reason to get excited about pro football's return. In the past...Blog | August 08, 2013
About Last Night: Working Hard, Harvey WorkingSpike Friedman
In case you were busy declaring that your rap career is one and done, here's what you missed in sports on Wednesday: Matt Harvey dominated the Rockies, throwing a four-hit shutout as the Mets took down Colorado, 5-0. Harvey entered the postgame ...Blog | August 08, 2013
111-Day NFL Warning: Wes Welker Switches Sides in the Brady-Manni...Robert Mays
What's that? You were wondering exactly how many days until the start of the NFL season? Well, you're in luck! We here at the Triangle are set to spend the next three and a half months providing a daily reason to get excited about pro football's retu...Blog | May 17, 2013
B.S. Report: Bill BarnwellBill Simmons
Bill talks to Bill Barnwell about Wes Welker's departure from the New England Patriots and other NFL free-agency moves. To listen to this podcast, you can download it on iTunes here or go to the ESPN.com PodCenter here....Blog | March 14, 2013
About Last Night: Wes Welker's Feeling a Mile HighSpike Friedman
In case you just saw the trailer for Upside Down and found yourself suddenly back to square-one on your big screenplay idea, here's what you missed in sports on Wednesday. Wide receiver Wes Welker has left the New England Patriots, signing a two...Blog | March 14, 2013