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Call Start: 09:00
Call End: 09:50
MannKind Corporation (NASDAQ:MNKD)
Q3 2008 Earnings Call
November 5, 2008 09:00 am ET
Matthew Pfeffer - Corporate Vice President and Chief Financial Officer
Hakan Edstrom - President and Chief Operating Officer
Peter Richardson - Corporate Vice President and Chief Scientific Officer
Alfred Mann - Chairman and Chief Executive Officer
Thomas Shrader - Rodman & Renshaw
Thomas Wie - Piper Jaffray
Michael Tong - Wachovia Capital Markets
Annabel Samimy - UBS
Thomas Russo - Baird
Cory Kasimov - J.P. Morgan
Leah Hartman - CRT Capital Group
Richard Diamond - Evolve Capital
Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation third quarter 2008 conference call. At this time, all participants are in a listen only mode. Later, instructions will be given for the question and answer session. (Operator's Instructions).
As a reminder, this call is being recorded today, November 5th, 2008.
Joining us today from MannKind are Chairman and CEO Alfred Mann, President and COO Hakan Edstrom, the Chief Financial Officer Matthew Pfeffer, and the Chief Scientific Officer Peter Richardson. I would now like to turn the call over to Matthew Pfeffer, Chief Financial Officer of MannKind Corporation. Please go ahead.
Matthew Pfeffer
Good morning, and thank you for participating in today's call. I will summarize our financial results for the third quarter of 2008 as reported earlier today. Next, Hakan and Peter will provide an update on key accomplishments during the past quarter, and finally, Al will comment on the current situation and our outlook going forward. We will then open up the call to your questions.
Before we proceed further, please note that comments made during this call will include forward looking statements within the meanings of federal securities laws. It is possible that the actual results could differ from the stated expectation. For factors which could cause actual results to differ from expectations, please refer to the reports filed by the company with the Securities and Exchange Commission, and the Securities and Exchange Act of 1934.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast, November 5th, 2008. MannKind's management undertakes no obligation to revise or update any statement to reflect events and circumstances after the date of this call.
Let's start with the financials. For the third quarter of 2008, total operating expenses were 69.1 million compared to 80.9 million for the prior quarter and 75.6 million for the third quarter of 2007. R&D expenses were 55.6 million for the third quarter of 2008 compared to 67.6 million for the prior quarter and 64.8 million for the third quarter of 2007.
These decreases in research and development expenses were primarily due to decreased costs associated with the clinical development of AFRESA, and the related manufacturing costs associated with the clinical trial materials, partially offset by increased stock based compensation expense and facilities related expenses.
General and administrative expenses were 13.4 million for the third quarter of 2008 compared to 13.3 million for the second quarter of 2008 and 10.7 million for the third quarter of 2007. These general and administrative expense increases were primarily due to increased employer related and consulting expenses, and increased stock compensation expenses.
For the first nine months of 2008, operating expenses totaled 224 million, compared to 228.3 million in the same period of 2007. R&D expenses for the first nine months were 181.7 million compared to 190.1 million in 2007, primarily due to decreased costs associated with the clinical development of AFRESA and the related manufacturing costs associated with the clinical trial materials, partially offset by increased stock based compensation expense and increased facilities related expenses.
G&A expenses increased by 4.2 million to 42.4 million for the first nine months of 2008, primarily related to increased employee related and consulting expenses and increased stock based compensation expense, offset by decreased professional fees.
The net loss applicable to common shareholders, stockholders for the third quarter of 2008 was 68.5 million or $0.67 per share lost, compared with the net loss applicable to common shareholders of 73 million or $0.99 per share for the third quarter of 2007.
The net loss for the first nine months of 2008 was 219.7 million or $2.17 per share, compared with the net loss of 218.2 million or $2.97 per share for the first nine months of 2007.
Our cash, cash equivalents, and marketable securities as of September 30th, 2008, totaled 95.2 million, compared to 180.5 million at June 30th, 2008, and 368.3 million at December 31st, 2007. Our cash burn during the past three quarters was 99.2 million Q1 '08, 88.6 million in Q2 '08, and 85.2 million Q3 '08.
We anticipate our cash burn to slowly decline over the next several quarters with the completion of our phase three trials and of our new manufacturing facility, subject to fluctuations in the quarterly burn rate over the next few periods due to the timing of our expenditures of our clinical trials and for capital costs for the new plant.
With the availability of the $350 million credit facility from Al (ph 00:07:46), none of which has yet been drawn, we continue to believe that we will be able to fund our operations into 2010.
I would now like to turn the call over to Hakan Edstrom, our President and Chief Operating Officer. Hakan?
Hakan Edstrom
Thank you, Matt. Good morning. As you may well understand, MannKind is focused on bringing the entire phase three program to its final conclusion at this time, allowing us to submit our NDA early in the first quarter of 2009.
The execution of our NDA filing package is proceeding on schedule including the additional bio equivalent study that was requested by the FDA in our July pre-NDA Meeting. We are also in the implementation mode of the first of our phase 3B trials study 119.
And as you will hear from Peter in greater detail, we have now closed all of our pivotal phase three studies and initiated data analysis. We expect to complete data review of studies 102 and 030 sometime in December and share it with you soon thereafter. Exact timing for press releases and presentations will be dependent upon NDA submission, workload submissions, and the AVA abstract deadlines.
The NDA file will be submitted, as I said, in the first quarter of 2009, upon completion of the inhaler by the equivalent study. This study is now well under way and will complete in mid-December. And since we have completed all pivotal phase three studies and the build out of our manufacturing operation in Danbury and with the NDA submission soon behind us, we are now transitioning from a development focused company towards commercial readiness.
And we are also undertaking a number of clinical (inaudible), phase 3B studies for AFRESA, that we expect will show its superiority as a brand of insulin compared to rapid acting analogues, and Peter will comment on the status of those studies a little bit later in this call.
Having all of the phase three clinical data in our hands shortly, we intend to reinvigorate our (inaudible) discussions in 2009 that was suspended last spring following the turmoil of Exubera. And given the current uncertain financing environments, we've also devoted significant time focusing on reducing capital spending and program expenses. That's allowing us to operate on existing funds and loans into 2010 with the potential of an NDA approval for AFRESA within this timeframe. This will however, not preclude us from making what we believe to be strategically important investments, if and when appropriate.
And in closing, let me touch upon one other item that's under way right now. As you know, we've signed the agreement with Pfizer to sue some of the Exubera patients that were left stranded when Exubera was withdrawn from the market. The transition of patients is under way and we have experienced a high level of interest from previous Exubera patients and their doctors. And now, here is Dr. Peter Richardson, our Chief Scientific Officer.
Peter Richardson
Good morning, and thanks, Hakan. Once again I am happy to be able to report that AFRESA, previously known as Technosphere Insulin has progressed according to plan over the past quarter. The preparation of our NDA is well advanced with the goal of submission early next year. The pacing event to filing is the bioequivalency study asked of us by the FDA. With the protocols that were submitted last month, and that trial has been initiated and is tracking to complete in time to meet our aggressive goal for filing.
I am very happy with the team's exceptional performance in getting this study up and running in record time. All of our phase three studies are now complete and databases have been locked in recent weeks. I don't have further data from the pivotal studies available to report today as we're following a carefully designed process to complete the many tables and analyses required for submission to the FDA, and with the internal consistency that will allow us to pull these in our integrated summaries of efficacy and safety.
Our goal is to be able to present abstracts from the main study for next year's meeting of the American Diabetes Association, but we will of course look forward to updating you with the top line summary data before the end of the year.
We've made good progress with the unveilment of our phase 3B program, and we are now actively recruiting in two of the three presently planned studies. MKC119 is a meals variation trial to demonstrate that carb counting and complex meal titration are essentially unnecessary with AFRESA. Additionally, this study will indicate what minimal sacrifice, a person's standard fixed dose of AFRESA may become excessive.
MKC117 is a three months treat to target study in type I patients comparing AFRESA plus Lantus to Humalog plus Lantus. Fasting glucose is targeted to below 120 milligrams per deciliter, using continuous glucose monitoring for safety. Lantus will be given in the morning or twice daily according to physician's judgment, and we expect this study to see superiority of AFRESA over Humalog in A1C and/or hypoglycemic risks.
We are planning another trial in type I patients, comparing AFRESA to bolus delivery of Humalog by an insulin pump. In both cases with basal insulin delivered by the pump. What we learned from the 009 study, as well as from experience elsewhere, is that we really need a better long acting insulin.
The currently available drugs don't last long enough for many people, and the kinetics are not physiologic, or even sufficiently flat. Many (inaudible) leaders insist on two injections of Lantus or Levemir daily to cover 24 hours. And even that does not create uniform delivery.
This study will demonstrate that superior control and even normal A1Cs can be more readily achieved with AFRESA plus a more physiologic stable insulin. MannKind has been evaluating several basal insulins and this trial will provide some thought for adopting a better basal insulin.
In addition to our phase three pivotal efficacy and safety studies, we now complete an enrolment in all clinical pharmacology studies to be included in our submission, other than the bioequivalent study requested by FDA at our pre-NDA meeting.
I am pleased to report that it is progressing well and we should have all patients treated by mid-December. Thus, 29 of the total of 30 planned clinical pharmacology trials are now complete and analyzed, or in the final stages of data analysis.
These studies can be divided into two groups; 19 early development studies were conducted before the final to be market formulation was determined, the results of which have been presented or published over the past few years, and 11 studies have been conducted with the to be marketed formulation.
In the last year, we have examined the pharmacokinetics of Technosphere insulin in subjects with chronic obstructive pulmonary disease, and in diabetics with active upper respiratory tract infections. We have also actively pursued the complete understanding of the FDKT (ph) metabolism and elimination, including the finding that dosing adjustments in patients with renal failure, or in those with chronic liver disease, will be unnecessary.
We have recently completed a cardiac safety trial, extensively evaluating any potential for FDKT to affect cardiac repolarization, even at a super therapeutic dose, as well as two studies characterizing the potential for integration with an inhaled bronco-dilator or steroid.
And finally, we continue to evaluate insulin pharmacokinetics in proportionality of escalating doses of TI, as well as the interchangeability of distant TI cartridge strength in subjects with diabetes.
All studies to date support the advantages of AFRESA.
The therapeutic robustness projected by the early phase AFRESA development program has been drawn out by years of focused critical assessment. The administration of (inaudible) inhalation powder produces an insulin PK profile never reported with any of the currently available insulins, either injected or inhaled.
AFRESA powder has a very rapid absorption with a time to maximum concentration, the Tmax, of approximately 12 to 14 minutes, with concentrations near baseline by 182 to 240 minutes. Consistent with this PK profile, the onset infection of insulin inhaled as AFRESA powder is much more rapid than subcutaneous insulin Lispro and subcutaneous recombinant human insulin. And the duration of action of AFRESA inhalation powder is shorter than subcutaneous recombinant human insulin, or insulin Lispro, which translates into lower glucose excursions post meal with a lower potential for hypoglycemia.
Aside from our AFRESA program, our cancer immunotherapy program has also made good progress. With our PT regimen in a variety of genotypes, we have already achieved the primary endpoint of the study with meaningful immunological responses being observed in 50% of patients, even of the low-dose group, well exceeding the prespecified success criteria of 25% in any group.
We look forward to seeing even better results in the high-dose cohort, the recruitment of which is now complete. And similarly, we have approached the end of recruitment with our MT regimen in melanoma. We look forward to reporting on these in more detail as we assess the clinical and immunological responses.
And now I would like to hand over to Al Mann, our Chairman and CEO. Al?
Alfred Mann
Thank you, Peter. We can now see the light at the end of the tunnel. All of our pivotal trials have been completed and our clinical staff is busy analyzing the data. As Peter noted, we recently reported top line data on the MKC103 and MKC009 trials, and will soon be in the position to present additional data on those and data on the MKC030, the two year safety and efficacy trial, and also on the MKC102, the one year type two efficacy trial.
Our clinical program has been very large and robust. More than 40 trials with more than 5,000 people in almost 300 clinics, so far presenting a consistent story of the unique benefits of AFRESA. Peter has described this program which was far more extensive than those of others exploring inhalation of insulin, and we believe we have more than met the FDA's draft guidelines for pulmonary insulin that was published earlier this year.
We have already reported that our team attending the pre-NDA meeting with the FDA on July 14th was pleased with the agency's responses to our questions. Our team leader said it was the most positive of the 18 such meetings he has attended throughout his career.
One additional request from the agency, as noted, was to conduct a small bioequivalency trial comparing the inhaler use in the clinical program to the commercial version of that device that is more rugged and less costly to manufacture. That trial is under way in Europe and Peter noted that the last patient's last visit is scheduled for mid-December.
Preparations for our NDA submission are progressing well, and even with this additional trial, the NDA should be filed shortly after year end.
Our trial program over these past three years has been directed toward regulatory approval. The over 300 clinics involved in these studies are located in the US, Europe, and Latin America. With such broad participation, we have seen that throughout the world, the general standard of care for diabetes is frightening. There is such fear of hypoglycemia that fasting glucose is managed at dangerously high levels. With such high fasting levels, it is no wonder that so few people reach target A1Cs.
We have also seen the current basal insulins are not physiologic, and we are committed to bringing a more effective and safer basal insulin to market. We have been evaluating several approaches to more effective basalcontrol. Together, AFRESA with a more physiologic basal insulin will create what I believe could become the standard of care for type I diabetes and for most of type II, certainly for those without gastroparesis.
As we continue to harvest the clinical data and move forward towards launch of AFRESA, we will soon be prepared to restart our partnership discussions that we suspended after the Pfizer announcement in April. Since that time we have continued discussions with potential partners, but have not conducted any negotiations. As we restart this process, we are now in a different and much more advanced situation.
Some of you have doubted that a relatively small company like MannKind can complete such a complex program and bring such a product to market, insisting that only a major pharma company could pull this off. To be sure, the job is not yet done, but consider what MannKind has already accomplished.
We have developed a therapy to reduce mealtime glucose (inaudible) and with an insulin that truly addresses the problems seen with early prandial insulins, resulting in unique benefits for patients with diabetes.
We have completed a comprehensive and robust clinical program to demonstrate the unique properties of AFRESA, compared against the present gold standards of insulin regimens in both type I and type II diabetes. We have demonstrated safety of AFRESA with our extensive preclinical and clinical studies. We see absolutely no indications of toxicity or carcinogenicity or pulmonary function impact. Our long-term safety study 030, was recognized by the American Association of Respiratory Care for setting new quality standards in pulmonary studies.
We have constructed and dedicated a manufacturing plant under budget and ahead of schedule that has already been equipped with the first of the modular equipment. This facility will be able to treat almost 400,000 patients, and further modular equipment installations will enable us to expand production to many times that level as revenues grow. We have demonstrated the capability to scale up powder manufacturing from clinical batches of tenfold larger commercial batches, with success on the very first batch.
We prepared for and held a very success pre-NDA meeting with the FDA, that our very experienced regulatory leadership described as the most positive they had ever experienced. Our five teams are on course in preparing the NDA submission which will include the bioequivalency study comparing our clinical and commercial inhalers.
What we have demonstrated in our very extensive program is AFRESA is the first and the only insulin today that really mimics the kinetics of a healthy pancreas in reacting to needles. With the so-called rapid acting insulins, about 60% of the glucose lowering activity occurs after the meal is already essentially digested.
They hypoglycemic risk from this excessive persistence leads to glucose management at such high fasting levels that there is danger. These high levels, coupled with the result in between meals glucose lowering, mask the advantages of AFRESA and prevent reaching normal A1Cs. Daylong snacking is employed to compensate for the lack of synchronization, adding to the problems of a person with diabetes.
Even more, more important maybe that not only is snacking needed with those insulins, but also the liver works very hard to deliver more glucose to deal with the persistent tail. By contrast, we have seen in our trials that AFRESA's elimination of that excessive persistence significantly reduces fasting glucose levels even long after AFRESA is gone from the body.
Although we have not yet established the mechanisms of action for this effect, it appears that the kinetic synchronization may restore more natural hepatic function by reducing the excess gluconeogenesis with current insulin. That, along with between meal snacking leads to weight gain and are needed to avoid hypoglycemia from that long persistence.
Interestingly, a key opinion leader recently commented that he has learned from continuous glucose monitoring that the current insulins are not nearly good enough. Indeed, AFRESA is truly different and fills a poorly met need today. It is the most effective drug for the control of prandial glucose excursion, and we are now alone in the market for pulmonary delivery of insulin and we expect to be so for the next four to five years or more.
Buoyed by the exceptional trial results, the manufacturing progress, and a revenue forecast supported by independent market research, our team is absolutely committed to, and confident, of success of AFRESA.
And now let us open up the call to any questions. Operator?
Question-and-Answer Session
Thank you. (Operator's Instructions). Our first question today comes from Tom Shrader of Rodman.
Thomas Shrader - Rodman & Renshaw
Good morning.
Alfred Mann
Good morning, Tom.
Thomas Shrader - Rodman & Renshaw
Hope you guys are enjoying the calm before the storm. So, Al, you are talking a lot about basal insulin. Is this a new molecule, is this someone else's that you like more than Lantus? Can you give us a hint of what you're talking about?
Alfred Mann
I can't really discuss it yet, Tom. It's not at a point where we can make it public, but we are looking at an interesting solution to the basalproblem.
Thomas Shrader - Rodman & Renshaw
Okay. And the trial where you try to get fasting glucose less than 100, is that 317?
Alfred Mann
No. It's 117, and the protocol, we try to get it down to under 110, but the doctors were so worried that we ended up it's under 120, but we're going to try to get as many as we can, at least with the AFRESA, to get them below 100.
Thomas Shrader - Rodman & Renshaw
And is that trial enrolling, or are you nervous that Lantus just won't let you do that trial the way you want to? Is that trial—are you going to do that with Lantus?
Thomas Mann
Is it rolling? Peter, do you want to comment?
Peter Richardson
Yes. It's actually enrolling and it's enrolling quite nicely at the present time. What we did there was we've actually gone and, after a lot of discussion with the opinion leaders, we actually changed the Lantus dosing from that which we used in '09 to allow for them to split the dose which is very commonly done in type I patients in order to try and smooth out the Lantus profile, because clearly what we've seen is that if you dose in the evening, you're really getting insufficient by 25 hours later to maintain that control.
And we want to be able to show that using Lantus in the best way we could and with the really very distinguished group of opinion leaders that we had on this study, they thought that was the appropriate way that we should approach this to show what AFRESA could really do if we got the best that we could for the basal insulin. Unfortunately, that requires twice daily dosing at the moment.
Thomas Shrader - Rodman & Renshaw
So the protocol is for twice daily Lantus or you will allow it? Will you stratify?
Peter Richardson
We had a great deal of discussion as to how to deal with it. It is allowed once or twice daily according to an investigator identified needs. So, it's not mandated in the protocol, but it is certainly something that quite a few investigators are already doing with their patients because they find others in need.
Alfred Mann
Let me add one more comment, Tom. One of the things that we have learned is, as we said, we would like to see a better basal insulin, but because we don't have it just yet that we can speak about, we are doing a trial to show that we can bring most people within normal A1C control with AFRESA plus what would be a better basal insulin. We're going to simulate that better basal insulin with an insulin pump.
Thomas Shrader - Rodman & Renshaw
Okay. And then one quick question on the changes to the inhaler. You talk about it being more rugged; are there pieces in the inhaler that actually come in contact with insulin? Are they all the same — or how big are the changes?
Peter Richardson
There's been no changes at all to the flow path, that was one of the things that we really took a great deal of trouble to make sure that we maintained. The changes are really around robustness, just getting some of the clicking, some of the things that give the feedback to the patient that have engaged this in the right position and also the cap which closes down over the cartridge, we've put a new fixator on that so that it maintains in place.
So the changes don't influence the flow path of the powder at all and are really all related to making it more robust and easier to manufacture in bulk, so that's why it was important that we did this. And I think that we've demonstrated this very effectively to the agency. They asked us to do a study to confirm that there were no differences between those two, and that we would certainly not expect to happen.
Thomas Shrader - Rodman & Renshaw
So we should think of it as kind of a cooler grip or something?
Peter Richardson
You could think of it that way.
Thomas Shrader - Rodman & Renshaw
All right. Thanks a lot.
Thank you. Your next question comes from Thomas Wie of Piper Jaffray.
Thomas Wie - Piper Jaffray
Hi. Thanks. Just wanted to ask a little bit more on the financial stuff and then a clinical question. Can you give us a sense of how much more needs to be spent on CapEx for the plan from now to the point of approval, and then also if you can give us a sense of where you expect the R&D expenses to level out at now that the phase three program is complete.
Matthew Pfeffer
Sure, Thomas. I'll try. That's a little bit hard to answer precisely. The capital spending for the plan is essentially done. There are small things happening there still, so it's going to go down to a fairly normalized level compared to what it has been.
If you look at the long-term trends on capital spending you'll see we, just in the last few quarters, we spent quite a lot, but prior to that it was much lower and if you go back as far as early 2007 it was running around the 6-7 million range compared to the twenties to thirties in recent quarters. It should get back to those kind of levels maybe a little bit more just to support a large infrastructure.
The R&D is a little harder to predict. We have a lot of studies going on. They're certainly going down with the completion of the phase threes, but giving precise guidance at this point would probably be premature.
Thomas Wie - Piper Jaffray
And the CapEx part with the additional modules that you could add, is that planned to be a post approval decision that you make?
Matthew Pfeffer
At this point, yes.
Thomas Wie - Piper Jaffray
And then I did want to ask a question about some concerns that have been raised about the delta between TI and NovoLog in the recent studies, and I understand that from a statistical standpoint you've met the criteria for non inferiority, but numerically it seems as though the TI arm seems to fall slightly short of NovoLog. Is there a risk of a meta analysis that's done on efficacy by the FDA and that they pool the data together and it actually looks statistically inferior?
Peter Richardson
Perhaps I'll take that one. The quarter point difference you mean is something that first of all we prespecified as being clinically insignificant when you design these studies. There's really very clear guidance in terms of what's considered non inferiority, we do meet that. And indeed the quarter point difference is really of no clinical consequence in the eyes of most of the opinion leaders that we've spoken to around this.
In terms of meta analysis, we don't anticipate that to be an issue, and obviously we haven't got the data of the upcoming studies, but I would anticipate that with the designs that we've had, with 102 in the type II population we're going against a premixed insulin. It's a different comparator. It's an important comparator in the type II ones and I would be anticipating that we'll have the best results there, and I would also be looking as we look across the studies that we've had, we will see a consistent pattern of efficacy from AFRESA.
Alfred Mann
Let me add one more comment, Tom. What I think maybe you need to consider is that when you're starting a very high fasting glucose level as we are, the problem that we see in our trials is that if you're using rapid acting analogue as a comparator, the post prandial reduction in glucose levels really offsets and masks the benefits that we have. When you get down near normal glucose levels and of fasting glucose levels, you're going to see enormous benefits from AFRESA compared to the other products, but you have, if you're talking about A1Cs, you're looking at the average and the average of the RAAs is masked or is really largely controlled by that drop in post prandial glucose levels which we don't have.
Thomas Wie - Piper Jaffray
That's very helpful. And then just kind of in that same vein, it sounds like this 117 study could be a very important marketing study from an efficacy standpoint. What are the powering assumptions to show superiority to the Humalog Lantus arm? What are you trying to show in that study?
Peter Richardson
Well, there are two things in terms of that. One, we have powered to look for a delta in HBA1C, I can't remember the exact number that we've chosen there. We've got about 500 patients participated into that study, one to one randomization between the two groups. And here we'll be looking very aggressively at bringing them down to target.
And if you notice in the '09, we saw absolutely no difference in the numbers of patients that we could get to target between those two treatment regimens. What we're looking at here is when you become more aggressive, what's the number of patients that you can get to the target goals that's less than seven and less than 6.5, and I think that that will be very—it's a very interesting outcome from this study at the edges of what you're able to do with present insulins.
Thomas Wie - Piper Jaffray
Thank you.
Thank you. Your next question comes from Michael Tong of Wachovia Capital Markets.
Michael Tong - Wachovia Capital Markets
Hi. Good morning. Just a quick question. I've been hearing some discussion that the FDA may be coming out with a revised draft guidance as it relates to the development of drugs for diabetes. Just wondering if you've heard the same thing, when you might expect the revised guidance to come out and whether you expect any impact on AFRESA?
Peter Richardson
Yes. I mean, earlier this year the agency, they've come out with a revised draft guidance. We've been through that in detail and indeed our program, we believe meets and exceeds the requirements that are in there. Obviously, this ongoing debate in this field, this is a draft guidance, agency guidance's often remain drafts for quite a long period and there will be further inputs.
So, I'm not aware of the date for the finalization of that guidance and nor have I anticipated anything in the guidance material to be different from that which they have issued which we appear to meet.
Thank you. Your next question comes from Annabel Samimy of UBS.
Annabel Samimy - UBS
Hi. Thanks for taking my question. Can you just go over the—I can't remember the number of the study, but it was the study with the Bolus delivery of the basal insulin by pump. Is that really to get the better coverage over 24 hours or is there another reason behind that one?
Alfred Mann
Well, the idea was simply to try to demonstrate that if you had a really good basal insulin along with AFRESA that you can get most people to normal A1Cs, that's what we really think we'll able to achieve with that study.
Peter Richardson
I think the important thing to understand is that really with a pump delivery, you're bolus is just not comparable to that which you can achieve with AFRESA because of the unique pharmacokinetics. So here we'll be comparing, trying to do the best that we can with basal therapies in terms of the pump, but then looking at an optimized pharmacokinetic regimen that can be done with AFRESA versus that which is possible using Bolus delivery from a pump.
Annabel Samimy - UBS
Okay. And all these phase 3B studies, they're strictly for marketing purposes or not necessarily any requirement of the FDA laid out for you?
Peter Richardson
They are not required. Clearly 117 is an important study. They're all being done to the standards that we would expect of clinical practice, but yes, they're primarily for marketing and also to help with reimbursement. We're targeting here for them to be available at the times we anticipate, working with managed care organizations and others where we'll be working with that and I think the data around these where we anticipate being able to show the real practical benefits of the product will be very important in terms of our pricing discussions.
Annabel Samimy - UBS
And do you have any ideas when these studies might be completed?
Peter Richardson
We're tracking to have them available so that they can be presented the following year in terms of time of launch and we'll be able to present those data at the time we anticipate arriving at a launch for AFRESA and that's been the plan that we've been following.
Annabel Samimy - UBS
Okay. And finally, is there any greater detail around the hypoglycemic events that you are analyzing—I guess it was the 009, that you're looking at more details around the hypoglycemic events; is there any further color on that?
Peter Richardson
Not as yet. What I hope that we'll be able to do is as we pull the hypoglycemic events from all the studies, we really want to put this into a context that comes across the program. We've now got the programs, the analyses, that we want to apply to all the studies. As it confirms the effect that we saw in 009 but I think we will also see in the type II population, greater benefit, a clearer benefit, and we want to present those in their entirety when we present the results from 102 and 030 shortly.
Annabel Samimy - UBS
Okay. Great. Thank you.
(Operator's Instructions). Our next question comes from Tom Russo of Baird.
Thomas Russo - Baird
Good morning, thanks for taking the question. I just wanted to return to Thomas's earlier question and ask it maybe in a little different way. If you do not meet the primary endpoint for non inferiority in A1C control, procedurally, is there still a path forward for the trial to be considered successful, and also, can you remind us which other trials are considered pivotal or registration trials that have A1C non inferiority as a primary endpoint?
Peter Richardson
Well, let's talk in terms of where we've been in the earlier studies, because the first criterions for sure are, are we safe and effective, and in terms of efficacy we have placebo control study in type II patients which is protocol 08. That demonstrated a significant reduction in HBA1C. Protocol 8005 again demonstrated a both dependent and statistically significant reductions in HBA1C in prandial glucose excursions. Those have been reported earlier.
In terms of the non inferiority design, we do meet the requirements of non inferiority. Remember, this is in the type I population, and I think that what is important to look at is the overall effects and clearly there is no question that insulin in this population is necessary and we have demonstrated very clear efficacy in that population.
Study 102 is a non inferiority design comparing, I think, mixed and that will be another pivotal study. And then 030 has a comparison. It's a safety endpoint, but of course we are looking at HBA1C and that's a large study with a population of type I and type II patients.
Thomas Russo - Baird
I guess what I'm just asking is if the range went outside of what was predetermined to be acceptable, does the FDA then look at some of the other benefits and the fast action and some of the other things that are unique, or is that potentially a show stopper for that trial?
Alfred Mann
Let me make the comment there. We have received—at least I have received some inputs from the leaders of the FDA that they are very concerned about post prandial excursions, not just A1C, and of course they are certainly qualified to understand the effects of the persistent tail that you get with other drugs that reduce A1C. So they are very conscious of what's going on and we don't think there is a problem, nor do we think we will have a problem in meeting the target of non inferiority.
Thomas Russo - Baird
Okay. And then second question, I think when the Pfizer deal was signed, one of the benefits you saw there was in getting some of the clinical trial data from those patients that were going to be transferred over to TI. I was just wondering if you've got any of that data yet and if there are any learnings that you'd be able to share.
Peter Richardson
I don't think I want to comment particularly on learnings. The collaboration with Pfizer around that in terms of addressing the patient need in this area has been very good. Both of us have a clear goal here in terms of making sure that those patients who need and can benefit from AFRESA who were previously treated with Exubera are transferred over carefully and we have had very good cooperation getting a full understanding and managing the implications of that and we're comfortable with that.
Thomas Russo - Baird
Okay. Thanks very much
Thank you. Our next question comes from Cory Kasimov of JP Morgan.
Cory Kasimov - J.P. Morgan
Hey. Good morning, guys. All but one of my questions have already been answered. I'm just now interested in your take on the FDA requiring a REMS program for Exubera, even though that project is no longer commercially available? So basically, do you believe there's any read through into any lingering safety concerns that the agency has for pulmonary insulin and also is this issue been discussed with you since these patients who were on Exubera have been or are being transferred over to AFRESA? Thanks.
Peter Richardson
To answer the second one, we've had no specific dialogue around the rems program with the agency. We of course have had agency input to the protocol by which patients are being transferred and we've collaborated closely with the agency in terms of making sure that they're comfortable with that.
In terms of the rems program and any impact for those, well, first of all I think you're going to see a lot more rems programs in the FDA. If you look at the details of what happened there, it was basically a transference of the previous risk management program, the risk map which Exubera previously committed to, and it seemed that the agency was formalizing that within the new rems mandate that they have.
We don't see a specific impact for AFRESA, we will of course by looking in terms of making sure that we have an appropriate plan for the risk management of a new product as you'd always be expected to do with any new product coming in, and we'll be looking at the best way of doing those with the agency as we approach the submission.
Cory Kasimov - J.P. Morgan
Great. Thank you.
Thank you. Your next question comes from Leah Hartman of CRT Capital.
Leah Hartman - CRT Capital Group
Thank you for taking the question. Just some housekeeping details, could you repeat please the capital expenditures for the quarter?
Matthew Pfeffer
Total capital expenditures were about $24 million for the quarter.
Leah Hartman - CRT Capital Group
Okay. And when you talked about, per Thomas's question about more normalized spending levels, is that more down towards the $5-6 million on a per quarter, or can you pull it in from there?
Matthew Pfeffer
I think it will be down in that range. It could be a little bit more, but the facilities are much larger and that's just a normal level of replacement. There's not any major construction program planned prior to commercialization, so it should get back to kind of normalized levels.
Leah Hartman - CRT Capital Group
And then with respect to the founder loan, you still have that full availability?
Matthew Pfeffer
Leah Hartman - CRT Capital Group
Okay. Thank you and best wishes in the coming weeks. It's very exciting.
Matthew Pfeffer
Thank you.
Alfred Mann
Thank you.
Thank you. And your last question comes from Richard Diamond at Evolve Capital.
Richard Diamond - Evolve Capital
Yes. Good morning, gentlemen. You have a new facility in Danbury. Can you take us through the path and the timeline to full commercial manufacturing please?
Hakan Edstrom
What we're doing right now, it's certainly—we're in commissioning in terms of the different components of the facility in making sure that we have a fully validated manufacturing operation in Danbury. We are currently in preparations for the PI inspections and we are actually working closely both with the FDA and the regional components of the FDA. So our plan certainly is that upon approval we will be fully validated and able to start manufacturing at that point in time, and as we have indicated, we have a modular approach and even with the first modules we're able to supply up to 400,000 patients of their daily medication. And so far we've been very, very successful in terms of our even going a scale to commercial scales from clinical scales. So upon approval, we expect to be able to start immediately manufacturing.
Richard Diamond - Evolve Capital
So, do we see this as a first quarter or a second quarter event just in terms of timing?
Hakan Edstrom
Well, I would say in terms of readiness, I would say that by the fourth quarter of 2009, we will be ready in terms of planning. Right now we assume that we will see a full FDA approval in the first quarter of 2010 and by that time we will certainly be able to assume the responsibility of commercial manufacturing.
Richard Diamond - Evolve Capital
Thank you very much. I appreciate it.
Hakan Edstrom
Thank you.
And at this time there are no further questions.
Alfred Mann
Thank you very much, ladies and gentlemen, for joining us today. Of course, we are in a period of completion of all of the work so there is not as much trial information to provide, but some of that will become public as the weeks proceed through the rest of this year. We thank you all for joining us today and we look forward to seeing you again at the next quarterly call.
Thank you and this concludes today's conference. You may disconnect at this time.
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- Item Piezoelectric Switch
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Fun Home
If graphic artist Alison Bechdel can't put the "fun" back in "funeral," her musical collaborators will give it a go. Sam Gold, Jeanine Tesori, and Lisa Kron present this Public Lab production, which portrays Bechdel's relationship with her closeted, undertaker father: "fathers, daughters, cartoons, caskets, and love."
Wednesdays-Sundays, 7:30 p.m.; Sundays, 2 p.m. Starts: Oct. 17. Continues through Nov. 4, 2012
Get the This Week's Top Stories Newsletter
Every week we collect the latest news, music and arts stories — along with film and food reviews and the best things to do this week — so that you'll never miss Village Voice's biggest stories.
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Worcester farmers look to rebuildSTAFF REPORT | March 18,2013WORCESTER Residents in Worcester are looking for help to rebuild a barn that burned to the ground earlier this month.
Edge Fuentes and Kate Spring were keeping their farming equipment in neighbor Hilary Dentons barn in Worcester when the barn caught fire on March 9. To replace the barn and equipment, the couple have started a fundraising campaign on the website www.gofundme.com. As of Sunday afternoon, the couple had raised $10,835 of their $20,000 goal.
The couple hope to continue operating their farm, Good Heart Farmstead, L3C. They say the mission of the business is to grow healthy, whole foods and to make them available to people of all income levels.
To donate, go to www.gofundme.com/goodheart-rebuild.MORE IN Vermont NewsMONTPELIER All three candidates for governor shared a table for the first time Thursday at a... Full StoryMONTREAL Giussepe Verdis Aida is certainly one of the best known and most popular operas of... Full StoryMONTPELIER Vermont in the 1970s was a hotbed for the counterculture, and the influx of young... Full Story
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Big-time jazz returns to Milwaukee
There was a time when widely known jazz stars included Milwaukee clubs and concerts on the music's national circuit. That ended decades ago, but there's a brief revival of sorts this week.
At 8 p.m. Friday, the Gerald Clayton Trio performs in the adventurous Alverno Presents concert series at Alverno College's Wehr Hall, 4100 W. Morgan Ave. »Read Full Article(1)
150 Milwaukee teens use film to speak out against violence
When 16-year-old Chanel Jackson was younger, the apartment building next to her Milwaukee home became a crime scene.
"All I saw the next day was the blood on the sheets coming out of the house," she said. "That's all I can remember." »Read Full Article(7)
Conor Oberst brings intensity to Pabst Theater
Describing the voice of Conor Oberst, many people have used the word "quaver," even after the indie singer-songwriter toned down the teenage trembling, as a 34-year-old man should.
At the Pabst Theater Saturday night, however, the word remained suitable for Oberst's live concert. His very body seemed to vibrate as if his nervous system was dosing his skin with extra voltage: Not enough to convulse him; enough to generate a low hum of surplus energy beneath his performance. »Read Full Article
PrideFest, Highland Games, Downtown Dining Week and Bay View happenings
On your mark, get set...
Go! Summer fun really begins this week. Two big festivals anchor different sides of the city next weekend, with PrideFest in Maier Festival Park and the Milwaukee Highland Games in Hart Park in Wauwatosa. And Jazz in the Park opens Thursday in Cathedral Square. Careful, it could be easy to overlook some of the other fun choices available. »Read Full Article
Festivals and free concerts in Milwaukee this week
Budweiser Pavilion:Wednesday Night Live presents The Toys, 7-11 p.m. June 4, Wisconsin State Fair Park, 640 S. 84th St., West Allis. »Read Full Article


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Math Competition Winners 2016
14 Apr
Deaf and hard-of-hearing middle school students from 34 schools around the U.S. and Canada came to the RIT campus to compete in the 11th annual Math Competition. More
14 Apr
Deaf and hard-of-hearing middle school students from 34 schools around the U.S. and Canada came to the RIT campus to compete in the 11th annual Math Competition. More
28 Mar
RIT's National Technical Institute for the Deaf has grown exponentially since enrolling its first class in 1968. Numbers don't tell the whole story, but they do give you a glimpse of what NTID looks like today. Check out NTID by the Numbers.
15 Mar
The performing arts program at Rochester Institute of Technology's National Technical Institute for the Deaf has launched an advisory committee to strengthen, support and advise NTID's theater program. The committee will engage in community outreach, promote greater community involvement in theater, increase opportunities for student participation and promote American Sign Language theater.
The NTID Performing Arts Advisory Committee's goals include establishing a summer theater program for deaf and hard-of-hearing high school and college students to encompass performance, stagecraft, cinematic studies, multimedia, directing and theater management; reviving RIT/NTID's acclaimed Sunshine Too troupe, a traveling group of six students—three deaf, three hearing—that performed in schools throughout the country for more than 18 years; establishing internship and co-op positions; and promoting the development of original work by deaf playwrights. More.
19 Jan
Rochester Institute of Technology is emerging as one of the world's most innovative, agile, diverse and forward-thinking universities. At RIT, we forge greatness by being different. We are a world leader in education and access for deaf and hard-of-hearing students. We have students who improve HIV medications in Africa, conduct remote sensing on volcanoes in Iceland, help select the Mars 2020 rover landing site, and win national cyber-defense competitions. And we have faculty who invent wearable technologies that protect soldiers, who work on the nation's top advanced manufacturing initiatives, and are named U.S. Professor of the Year.
This is just a start. Check out the RIT Points of Pride website.
22 Dec
Join us in taking a look back with pride on another outstanding year at RIT!


text: University of Montana UM Enrollment Official Talks SCOTUS Affirmative Action Ruling By Mara Silvers • Jun 23, 2016 YouTube Listen Listening... / 1:14 UM Enrollment Official Talks SCOTUS Affirmative Action Ruling Thursday morning, the U.S. Supreme Court ruled in favor of University of Texas at Austin's affirmative action plan. Staff in the admissions office at the University of Montana say that at least in the immediate future, not much will change. Montana Responds To Orlando Shooting With Pride Rally By Mara.Silvers • Jun 17, 2016 Mara Silvers Listen Listening... / 2:37 Gay Pride Rainbow On Display At UM's Main Hall Organizers are expecting more than 1,500 people to attend the Big Sky Pride celebration in Great Falls this weekend. But following the mass shooting at a gay club in Orlando this past weekend that left 50 people dead and 53 more injured, Big Sky Pride President Kev Hamm of Helena says he hopes the event that starts this afternoon will draw a much bigger crowd. Close to 5,000 people attended last year's parade in Missoula. The weekend celebration includes meals, entertainment and dancing, along with a bike ride, parade and rally on Saturday. It is open to all members of the lesbian, gay, bisexual and transgender community, and those who support them. In Missoula, nearly 100 people gathered in front of the University of Montana's Main Hall last night to see a rainbow. The plain brick building was lit with the colors of the gay pride flag to support the victims of last Sunday's massacre in Orlando. UM President Engstrom Named 'Administrator Of The Year' By Bree Zender • May 19, 2016 Josh Burnham Listen Listening... / 0:43 UM President Engstrom Named 'Administrator Of The Year' University of Montana President Royce Engstrom received an award today from the Montana Associated Students. Much Ado About Shakespeare! By Chérie Newman • May 18, 2016 Creative Commons: Patty Mooney Listen Listening... / 5:29 Students from Florence Carlton High School, and their teacher talk about their interpretation of William Shakespeare's play Romeo and Juliet. And Beverly Ann Chin shares information about free educational workshops: Best Practices for Teaching Shakespeare. Students at Florence Carlton High School in the Bitterroot Valley have been rehearsing a scene from William Shakespeare's play Romeo and Juliet. But this isn't a traditional interpretation. Derk Schmidt, who teaches English and drama at FCHS, says they've chosen an unlikely setting for the story. University Of Montana Receives $1 Million Toward Endowed Professorship By Sean Robb • May 4, 2016 Josh Burnham Listen Listening... / 0:56 University Of Montana Receives One Million Dollars Toward Endowed Professorship The University of Montana received a $1 million donation today towards an endowed professorship in finance. UM Student Newspaper Proposes Fee Increase By MTPR News • Apr 28, 2016 University of Montana's student newspaper, the Kaimin, says it will have to cut staff if it doesn't get a proposed $1 fee increase students are voting on this week. Montana Supreme Court Hears Arguments In Krakauer Student Records Case By Corin Cates-Carney • Apr 27, 2016 Corin Cates-Carney Listen Listening... / 3:36 Montana Supreme Court Hears Arguments In Krakauer Student Records Case Listen Listening... / 95:54 You can listen to the entire hearing by clicking here. The Montana University System challenged bestselling author Jon Krakauer in a state Supreme Court hearing Wednesday. In 2015, Krakauer released the book "Missoula: Rape and the Justice System in a College Town," examining how the University of Montana handled cases of alleged rape. One of those cases involved former UM student and quarterback Jordan Johnson. Krakauer Case Tests Balance Between Privacy, Right To Know By Corin Cates-Carney • Apr 26, 2016 Cheri Trusler Listen Listening... / 1:43 Krakauer Case Tests Balance Between Privacy, Right To Know The Montana Supreme Court is in Bozeman Wednesday, hearing oral arguments in a case between an investigative journalist and the State of Montana. Jon Krakauer, author of 'Missoula: Rape and the Justice System in a College Town', is pressing the State Commissioner of Higher Education to release disciplinary records related to former University of Montana student and athlete Jordan Johnson. UM Hosts Indian Law Week By MTPR News • Apr 8, 2016 Listen Listening... / 0:38 UM Hosts Indian Law Week The University of Montana's law school will look at the issue of cannabis in Indian country next week. It's part of the school's annual "Indian Law Week." Majority Of Montanans 'Very Concerned' About Climate Change By Eric Whitney • Mar 28, 2016 David J. Laporte (CC-BY-2) Listen Listening... / 5:47 University of Montana Political Science Professor Christopher Muste talks about survey findings on Montanans' attitudes about climate change and tribal sovereignty. A majority of Montanans think climate change is a very serious concern for the state. That's according to a poll commissioned by the University of Montana and Stanford University. UM Political Science Professor Christopher Muste helped conduct the survey. Pages« first ‹ previous 1 2 3 4 5 6 7 8 9 … next › last »


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Will more severe sanctions work?
Penalties will be harder for Russia to shrug off
By The Mercury
The United States and the European Union, which in recent weeks levied sanctions on Russia that had more symbolism than impact, on Tuesday imposed sanctions that are worthy of the name.
Read More ...
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Quality Inn Tupelo Guest Reviews
Write a review
|2.2 miles from Tupelo centre
Write a review
Frankl Tue, 2 August 2016
Disliked: Bath room was terrible! Commode was extremely uncomfortable, wrong size, water level in commode was so high you could not clean yourself without getting hand in water! I would never stay there, Quality Inn should pull their name from this poor excuse of a motel! Worse experience I have had in a very long time!
Anonymous Thu, 28 July 2016
Liked: Nothing to really like.
Disliked: Old place, with uncomfortable bed and very small pillows. Air conditioner was loud with insulation sticking out the bottom of it. Staff called police at 12:00 am due to yelling and screaming outside my room, and complaints from other visitors.
Kebell Tue, 26 July 2016
Liked: It was a great and comfy place to stay.
Disliked: There was no "business" computers. I had to print something for what we were there for, the printer didn't work and there was no way to save a document for the front desk to print. Ended up in a different hotel to print.
Jessica Thu, 21 July 2016
Liked: The beds were clean and soft and there were plenty of pillows. The bathroom was very clean.
Disliked: Didn't get the room I reserved, though the staff made a speedy fix of the problem.
Myrtle Wed, 20 July 2016
Liked: staff was friendly and very accommodating. Good price for the accommodations.
Disliked: Can't think of anything that I really did not like. Have stayed at this facility before and prefer a room on the front.
Kim Sat, 16 July 2016
Liked: Nice clean room. Very friendly staff and fabulous breakfast. Couldn't ask for much more.
Kfilly Tue, 12 July 2016
Liked: Good Night's Rest. Bed was comfortable. Plenty of hot water. Room smelled clean. Overall very happy
Disliked: Better breakfast.
Kfilly Tue, 12 July 2016
Liked: The overall stay was nice. Had a good nights rest. Customer Service was excellent from the staff.
Disliked: The room smelled a little funky. The off brand food was a little hard to tolerate.
Bd Mon, 4 July 2016
Liked: Comfortable bed.
Disliked: Check in agent reluctant to honor request for less secluded room.
Traci Mon, 4 July 2016
Liked: Location and staff were great
Disliked: The place looked and smelled really old and musty


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$799 2 bed 2434 W Webb Ave, Burlington NC, 27217
$799 2 bed
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This apartment is in Burlington. The closest park is Glen Rayen Park.
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ft! All apartment homes have both a sunroom office and balcony! Community features a Swimming Pool with Sundeck and Picnic area. Minutes from Greensboro, 4G9B6W Burlington, Elon and Mebane - making this apartment community perfect for commuting to work or school! We will have a 2 Bedroom unit.. Price from $799
Owner/manager tools | Report bad listing | From rentjungle.com
Burlington, North Carolina, 27217
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School holidays at South Perth Libraries
From story time to craft activities, movie nights and lego play time, there's something to suit every age group.
Community Safety Month
Join WA Police, Constable Care and the RAC for a month of free safety activities and workshops.
Evolve. development programme
A range of free and affordable workshops for new and emerging artist running throughout September.
2016 Emerging Artist Award Exhibition
City of South Perth Community Hall from Friday 21 October to Saturday 29 October 2016. Vote for your favourite artwork or purchase a piece to take home!
Events at your library
View a range of events for adults, teens and kids at South Perth and Manning Library.
Garage Sale Trail
One big day of Garage Sales happening right across Australia on Saturday, 22 October 2016.
GBLC StrEATS
Food Trucks every Wednesday to Sunday from 4.30-8pm.
Upcoming Events
Events Listing
GBLC StrEATS
Treat yourself and let someone else cook for you - there will always be something to tempt your tastebuds and warm you up this winter. GBLC StrEATS has relaunched and is bigger and better than ever - now with more food vans on offer!
Intermediate English Classes
City of South Perth Libraries will be running weekly intermediate English classes for adults on Thursdays from 4 August until 20 October 2016.
Evolve. development programme
A series of low cost artist workshops and professional development sessions throughout August and September.
Screen Printing & Natural Dyeing Workshop by Louise Snook
Learn two exciting textile techniques - screen printing and natural dyeing. Students will develop four colours using locally sourced plants and they will be introduced to the cut stencil method of screen printing.
September School Holidays at George Burnett Leisure Centre
The City's George Burnett Leisure Centre September school holiday program is open for registrations and encourages children to have healthy, active lifestyles whilst learning new skills.
Emerged Artist Talks by Artsource
A series of artist talks from Claire Bushby, Jurek Wybraniec, Dr Perdita Phillips and Antony Muia sharing their experience of the changing face of 'emerging' since the 1970's.
Author Talk Special Edition with Graeme Simsion
South Perth Libraries and Dymocks Garden City are proud to present Graeme Simsion author of The Rosie Project 'in conversation' with Natasha Lester author of A Kiss from Mr Fitzgerald.
Community Safety Month
The City has partnered with organisations during Community Safety Month to deliver a series of events and activities during the month of October.
5th Rotary Car Show
The Rotary Club of Como presents the 5th Rotary Car Show on Sunday 2 October 2016. Supported by Wesley College, South Perth.
Gone in Less Than 60 Seconds
The Gone in Less than 60 Seconds display car will challenge people to find valuables in a bid to show how quickly car theft can happen.


text: allyouneedis Play via YouTube OPEN IN APP NSFW Safe Is this playlist safe for work? gold finals December 13, 2011 | 43 tracks | 1,414 120 | Stats Iron & WineJohn PowellNorah Jones instrumentalsoundtrackeasy listening Liked Collect Share Edit celebrate Liked! Share this mix with friends: finals Wrong video Collect Share Liked! Share this mix with friends:


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Delivering on half its title, "Supercross: The Movie" is a full-throttle orgy of soaring bikes and revved-up engines. Completely disposable yet rousing, this noisy 20th Century Fox outing looks to sputter and stall in wide release, although homevid biz, particularly among motorsports enthusiasts, looks more promising.
Delivering on half its title, "Supercross: The Movie" is a full-throttle orgy of soaring bikes and revved-up engines, held together by a thin if capably acted story of sibling rivalry. Completely disposable yet rousing on its own crude, testosterone-saturated terms, this noisy 20th Century Fox outing looks to sputter and stall in wide release, although homevid biz, particularly among motorsports enthusiasts, looks more promising.
K.C. and Trip Carlyle (Steve Howey and Mike Vogel) are diehard devotees of Supercross, an offshoot of motocross racing known for its stadium-confined tracks and super-steep jumps. (Pic was co-produced by Clear Channel Entertainment's motor sports division.)
Making a temporary living cleaning pools around their native Palmdale, the brothers see their fortunes change after a pivotal tournament in Apple Valley, when K.C., the more responsible (if less naturally gifted) racer of the two, wins a lucrative contract with Supercross factory Team Nami.
What starts off looking like a sweet deal quickly turns sour as K.C. finds himself playing second fiddle to star rider Rowdy Sparks (Channing Tatum), a cretinous spotlight-hog with a nasty streak. As Rowdy's wingman, K.C. is forced to fight off the competish but never allowed to win a race himself.
Meanwhile, K.C.'s relationship with his brother grows more strained, as Trip, who's both proud of his sib and disappointed at being passed over, licks his wounds in increasingly volatile ways. With some prodding from gruff racing vet Earl Cole (Robert Patrick, bringing a welcome touch of gravitas), Trip decides to go pro on his own, allowing the pic to offer some wry insights into the life of a privateer versus that of a corporate stooge.
Though they're playing fairly standard types, Howey and Vogel delineate the two brothers expertly, nailing their hotheaded, competitive yet still affectionate vibe. As the more interesting character of the duo, Vogel is especially good, playing Trip as a mixture of reckless goofball and brooding black sheep.
The female characters tend to get lost in a film about a male-dominated culture. K.C. falls for a posh Palmdale girl named Zoe ("One Tree Hill's" Sophia Bush), while Trip falls for sharp-tongued fellow racer Piper (a tart, charming Cameron Richardson). To their credit, screenwriters Ken Solarz and Bart Baker do attempt to involve and flesh out both femmes; at one point, Zoe blanches when someone suggests K.C. owns her. (Still, this is the kind of movie where, after Richardson snaps at someone, "Stop staring at my ass," the camera helpfully supplies a closeup.)
Physical and emotional tensions between K.C. and Trip, compounded by Rowdy and a fourth racer (real-life motocross athlete Tyler Evans), build to a genuinely tense pre-climactic race in which neither the outcome nor auds' rooting interest is predictable. Near-fatal consequences ensue, after which the story quickly goes flat en route to its Las Vegas finale, resolving the central conflict in hasty, dramatically unsatisfying fashion.
While the nature of Supercross doesn't lend itself to fluid photography, the racing sequences, which incorporate actual footage from Clear Channel's events, are energetically cut and easy enough to follow. Riders' helmets no doubt made it easy to mask the stunt work.Unfortunately, director Steve Boyum is unable to get inside those helmets psychologically. A few blurry rider-POV shots are sprinkled throughout the finale to clumsy effect.
Off the racetrack, the pic's grainy interiors are almost uniformly, perhaps deliberately, underlit.


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1 Review
Wonderful! Both the salmon and relish were great in themselves but combined all the flavours came together perfectly. I used a BBQ and served along with a salad, with most of the work done in advance it all comes together quickly at the end and makes a perfect outdoor meal for warmer months.


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Frank Langella: "There is nothing wrong with walking on a set with an empty brain and then on action allowing your adrenaline and your trust in yourself to take over"
Langella speaks about not only how he typically chooses and prepares for roles, but how he rose to the challenge of acting against a robotic...
Frank Langella: "You really just need the platform and the actor, another piece of humanity, sharing his humanity with the audience"
Frank Langella won a Tony for playing a very unappealing Richard Nixon in Frost/Nixon, but that wasn't his only run as the "bad guy" of...
Sarah Paulson: "I muscled a lot of what I've achieved by sheer force of will and relentless determination"
"If my career had turned out like the fantasy I had of what it was going to be, it would never have made me happy" - Sarah Paulson
Boyd Holbrook on Shooting 'Narcos' in Colombia: "It was the most difficult thing I've ever done"
Holbrook talks about working with the real-life Steve Murphy, what movie inspired his narration, and why shooting in Colombia was so challenging.
How Joseph Gordon-Levitt Developed his 'Snowden' Voice
"You're playing someone that everybody in the world has seen before. It's a little different than playing a fictitious character." - Joseph Gordon-Levitt
Renée Zellweger on Returning to Film After a Six-Year Absence: "I needed to grow as a person in ways that didn't revolve around my work"
Zellweger talks about what prompted her six-year absence from Hollywood, what's different about playing Jones again, and ageism in Hollywood.
Dev Patel: "I want there to be people that look like me represented on screen"
"There aren't many roles written for someone that looks like me. It's slim pickings. It's difficult, but I try and stay on the optimistic side." - Dev Patel


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Bethany Baptist Church had a booth at the Heart of the Ozarks Healthcare Center, Friday evening. They had a game of tic-tac-toe and gave candy and gum to the winners. They also handed out flyers advertising the movie, "Last Ounce ...Read More »
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I spent a few days with Barb and Jack last week. One day Barb came from Mountain Grove and took me to the S&H Fish Farm. I caught a nice catfish. Bob and Linda have been helping get my yard ...Read More »
Ava Senior Center
The menu for this week is: Monday, July 8—Sweet and sour pork, rice, egg roll, Oriental vegetables, brownie. Tuesday, July 9–Taco salad, Mexican corn, fruit crisp. Wednesday, July 10—Roast beef, mashed potatoes and gravy, green beans, roll, hot apples. Thursday, ...Read More »
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Bonnie Phipps told me that the families all met at Michael's home Friday to watch the fireworks at the nursing home, those present were Michael and Wendee Freeman, Matt, Madison, Sydnee and Alexis, Bonnie Phipps, Cecilia Edwards, Roy and Linda ...Read More »
All Around Bradleyville
Beautiful weather for the last of June and first part of July. It is really nice for those that have to work outside. The birds were singing this morning like it was early spring so I think they must enjoy ...Read More »
AHS Annual Picnic Held June 22
The annual Ava High School Picnic was held Saturday, June 22, 2013 at the First Southern Baptist Church in Ava. Russell Sanders asked the blessing for the bountiful potluck lunch. Everyone enjoyed being inside out of the heat and appreciated ...Read More »
Little League Softball and Baseball Schedules
T-Ball Little League Field Thursday, June 27 6:00 Adams Backhoe vs. State Farm 7:00 Squires Fire Dept. vs. Stillings's Construction 8:00 Collins Law Firm vs. Danny Cutbirth Logging Monday, July 1 6:00 Squires Fire Dept. vs. State Farm 7:00 ...Read More »
Calendar of Events
This column is provided to our readers free of charge to announce upcoming events that are free to the public. Publication of the same announcement will be limited to two insertions. * * * Bible Study Tuesday night at Faith ...Read More »
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text: We stayed 2 nights at a lakefront cottage here and absolutely loved it. The cottage is clean and very well-equipped. Diane who manages everything made a special effort to ensure we were comfortable each day. The location is excellent and lake facing. My parents visited the island for the first time and had a really memorable experience. There are grocery... 更多


text: Cannabi$ by The Reckless Zebra published on 2014-08-15T22:21:54Z qwegjkbdfhjaj Genre Hip Hop Comment by NAUUDA Not really much to say rather than the fact that it is a chill hip-hop beat. The only thing missing is some fat vocals to not make the song sound too repetitive. 2014/08/23 20:46:34 +0000 Comment by DJ Bouncin(Bouncin Beatz) well made track, could imagine a nice dub bassline over this 2014/08/23 19:55:43 +0000 Comment by T-Rennix very repetitive, it got a bit boring, it needed some vocals or something to break it up, like maybe bring all those instruments in one by one and out one by one :) 2014/08/23 12:27:23 +0000 Comment by Jesus Avila (official) This is what I'm talking about! Living this groove. That bass though, LOVE IT! 2014/08/23 12:26:45 +0000 Comment by Ramen G Simplistic and to the point. Lyricists love that. The listener to pay attention to them that way. I'm thinking some transient shaping be applied to kick and snares to bring to the front more. Cram into a quality limiter for phatess. I recommend Dominion by digitalfishphones for transients and ferric tds for liming. 2014/08/23 03:25:46 +0000 Comment by Katon Venturi Black really awesome low slung singlular form bassline in here..i think that works really well to drive those single chords at the 1.40min mark..the bellish sound reminds me alot of RPG type games and this kinda music would also work well in the kinda environment so consider working up these tracks to big gaming industries as well! 2014/08/23 00:00:46 +0000 Comment by Jeff Jericho I would just find a way to give the beat more dynamics with some effects and panning techniques 2014/08/22 23:17:18 +0000 Comment by aondoe I love the sounds, but feel there could be more variation in the sections between 2:00 and on with the exception of 1:30 to 1:50. I love that breakdown! That part was the best part, overall pretty good track. 2014/08/22 22:36:18 +0000 Comment by wingwong Dude soooo chill, love it man, nice! 2014/08/22 21:18:38 +0000 Comment by 【 DVS 】 a little repetitive, lovin the smooth bass and the sub bass kicks! 2014/08/22 20:07:59 +0000 Comment by juff Freaking sweet production dude, i love that piano and the chords. But the hardest work was on those percussion. Sweet stuff man, love it. keep up the good work 2014/08/22 19:40:49 +0000 Comment by Get Dangerous strait banger dude, the flows on this song are dope as hell, very unique hip hop sound you got here bro. Really enjoying the vibes you put off in your music 2014/08/22 18:45:15 +0000 Comment by KRMAmusic Really digging the direction of this track. Would like to hear more in the soundscape and such though. Maybe a little more movement. Keep cranking bro. :) 2014/08/22 17:57:10 +0000 Comment by Zazzledub great atmosphere. Nice and relaxed drums. they sound very natural. Love that. Great keys. 2014/08/22 16:40:57 +0000 Comment by Matti_ice__ a very tranquil beat. the type you just flow about your day, a modern ice cube 'today was a good day' type of beat 2014/08/22 16:29:05 +0000 Comment by RINZSULIN Great hip hop production nice percussion and synths to bring it in slow then the drums hit you hard. 2014/08/22 13:39:58 +0000 Comment by Alebrand Muy buen manejo de bajos, buenas confinaciones de sonidos !! 2014/08/22 13:32:42 +0000 Comment by Bad Tempo Loving the percussion, here. I can tell you spend a lot of time into your arrangements.... Good stuff. 2014/08/22 12:40:05 +0000 Comment by Redlite This is a Pretty cool beat brah. Is that a Gangstarr sample? it reminds me of Mass Appeal so much. We should work on soemthing man 2014/08/22 11:37:12 +0000 Comment by Towley(XentriK) Love it, very chilled! Nice beat to it 2014/08/22 09:59:11 +0000 Comment by Demitri Medina Official 840 double blaze it. :P respect. Very awesome feel. Love the minimalistic vibe and the simplicity that is in this song. Nice choice on the samples and chord progressions. 2014/08/22 07:20:39 +0000 Comment by Digital Vapor Music Great on the track. Like the piano line going on in the track. The beat has a good groove and feel to it. Great job overall. 2014/08/22 04:47:02 +0000 Comment by Cody Thomasson starts slow then picks up, could use lyrics 2014/08/22 04:18:05 +0000 Comment by Austin Sperry i really like this beat, very clean and rythmatic, its almost like a reggae song for cold weather, or at least feels that way to me :) 2014/08/22 04:08:37 +0000 Comment by F.I.D.O the beat is quite nice and chilling plucks in the back ground really good tho waiting to hear a vocal version 2014/08/21 19:17:09 +0000 Comment by DannyArmand nice track! definitly can see someone flowing on this pretty dope! great work! 2014/08/21 15:11:27 +0000 Comment by 𝕃𝕠𝕘𝕚𝕔 𝕃𝕖𝕧𝕝𝕤 bättre mix på kicken är svår som fan å höra, dåligt mixat på just den delen, resterande delar va fett 2014/08/21 11:19:05 +0000 Comment by Rio Noir dope underground hip hop to rock too. perfect entrance to a new artist as well. loving the production on this one. cant wait to hear more of your beats! 2014/08/20 04:07:12 +0000 Comment by Fully Loaded Eclipes this beat is crazy dope keep up the good work!! 2014/08/19 21:52:49 +0000 Comment by Ambi-DXtrous Love the bell sound it's very melodic. Maybe turn up the kick about 2 db to give it the knock! 2014/08/19 19:18:03 +0000


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Suspicious fire destroys car dealership in SacramentoUPDATED 11:39 AM PDT Aug 10, 2012
Firefighters in Sacramento worked overnight to put out a fire at an abandoned car dealership that has repeatedly suffered from break-ins.
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Rolling Stone on Yahoo Music
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Critically acclaimed New York electronic artist Nicolas Jaar is finally releasing the proper follow-up to his 2011 debut 'Space Is Only Noise.' We talked to Jaar about electronic-music resistance, Nina Simone and the legacy of his artist father.Rolling Stone
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David Crosby, the Crosby Stills Nash & Young singer, shares some hard-won life lessons on latest 'Rolling Stone Music Now' podcast.Rolling Stone
Shepard Fairey's Noise: Inside Iconic Designer's New Art-Pop Band
Shepard Fairey's new art-pop band Nøise recently got the remix treatment by Moby, Z-Trip and more. We find out how this quartet allows the iconic artist to work outside of his lane.Rolling Stone


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Description from the manager
Description from the manager
Bedrooms: 4/
Bathrooms: 3/
Sleeps: 8/
Type: House
Book this 4 bedroom, 3 bathroom house in Cape May Point today! A total of 8 people can sleep here comfortably.
Guests can enjoy a deck, outdoor grill, and air conditioning among other amenities offered by this rental.
No travelers have shared a review of this property yet.
Costs vary, with the average weekly rate as low as $2,600.00, depending on travel dates.
The owner last updated the property's calendar today.
About the manager
About the manager
DeSatnick Real Estate LLC
DeSatnick Real Estate LLC
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