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OT -
"what" is going to be the impetus to propel us out of this recession
HGSI has been on a tear since about a week ago.Up about 20%. Anyone knowledgeable enough of chances whether primary endpoint (patient response) for lupus trial has a better chance of being stat sig at 52 or 76 weeks?
stents - I will admit that i am clueless about the stent business. However I am curious which portion of that post you are stunned about, the figures on the stent business, and/or the call on shorting stj and co, and/or the expectation that anpi will somehow reach $10?
EXEL - Maybe because it has more than 400 million in debt and only 270 million in assets before the 140 million.
mdvn
you have to consider the position of those buying the offering and you have to give them something to look forward to, they wouldn't want to buy at what looked like the top
Raising capital before the kneejerk sell on news makes a lot of sense, IMHO
MDVN - Raising money before their presentation on saturday, which was advertised as being part of the best of ASCO, is surprising. One would have assumed that they would wait till next week after the presentation.
http://finance.yahoo.com/news/Medivation-Announces-Pricing-prnews-15364766.html?.v=1
MAPP - Confirmatory trial?
"At the request of the U.S. Food and Drug Administration, Mountain View, California-based MAP will conduct a second trial to confirm the results.
Nelson said the company was still designing the second trial but that he expects it will not be as large as the first."
http://www.reuters.com/article/marketsNews/idINN2536961620090526?rpc=44&pageNumber=2&virtualBrandChannel=0
Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ:ALTH - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company also announced that the FDA has granted the NDA priority review status and established a Prescription Drug User Fee Act (PDUFA) date of September 24, 2009 for a decision regarding approval of the NDA. Priority review designation is assigned to drugs that have the potential to provide a significant improvement compared to marketed products or provide a safe and effective therapy where no satisfactory therapy exists.
“We are pleased the FDA has accepted our application for filing and granted it priority review status, a designation that emphasizes the significant need for new agents that advance the treatment of patients with relapsed or refractory peripheral T-cell lymphoma,” said Paul L. Berns, president and chief executive officer of Allos Therapeutics, Inc. “Over the next several months, we will continue to work closely with the FDA to support their review of the NDA. If approved, pralatrexate would be the first agent approved by the FDA for the treatment of patients with relapsed or refractory PTCL and represents a potential first-to-market opportunity for Allos.”
The NDA is based on the results from the Company’s pivotal Phase 2 trial known as PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma). The PROPEL trial was conducted under an agreement reached with the FDA under its Special Protocol Assessment, or SPA, process. Pralatrexate has orphan drug designation and fast track designation in the U.S. for the treatment of patients with T-cell lymphoma and orphan medicinal product designation in Europe for the treatment of PTCL. The Company believes the PROPEL trial is the largest prospectively designed single-agent trial conducted to date in patients with relapsed or refractory PTCL. The Company retains exclusive worldwide rights to pralatrexate for all indications.
http://finance.yahoo.com/news/Allos-Therapeutics-Announces-bw-15343853.html?.v=1
OGXI
Otherwise, they'll probably sell some shares soon given the recent run-up so that's another factor to consider.
ALTH - More reasonable numbers from Adam
Allos' pralatrexate addresses a small population of about 5,000 patients with peripheral T-cell lymphoma (PTCL) in the U.S., but the drug would be the first approved to treat the disease. Today, PTCL patients are generally treated with a hodgepodge of chemotherapy regimens, none of which work very well.
I'd put pralatrexate peak sales in the U.S. between $200 million and $400 million (assuming premium pricing), with upside coming from expanded use in other cancers, including lung, if such use is justified by clinical data.
http://www.thestreet.com/story/10504525/4/biotech-stock-mailbag-gilead-still-got-it.html
My calculator is indeed very flawed. how embarrassing. The treatment cost now seems abnormally large.
DNDN blurb
"Rodman & Renshaw, an investment bank that caters to raising money for small-cap biotech companies, initiated coverage on OncoGenex with a buy rating, making the claim that OGX-011 could be a more effective prostate cancer drug than Dendreon's Provenge."
http://www.thestreet.com/story/10503638/2/tiny-biotechs-dancing-in-the-bull-pen.html
ALTH
Allos assumes the PCTL market for pralatrexate will reach a peak of about 475 million in 2013 with about 6200 patients treated. Treatment cost then comes to about 7500 per year which seems absurdly low. Anyone have any thoughts as to why its so low? I was thinking of about 10-15 k.
OT Layoffs aren't the main problem
May 15, 2009, 11:38 AM
Layoffs Aren’t the Main Problem
By DAVID LEONHARDT
What makes the Great Recession different from all other recent recessions is not mainly the number of workers being laid off. It’s how few workers are being hired.
Look at this chart, from the Labor Department’s latest report on labor turnover (which Catherine Rampell also wrote about recently):
It makes the current recession look qualitatively different from the 2001 recession, right?
The line in the chart is showing the rate at which employers hire new workers. (To be more precise, it is the total number of workers hired in a given month, divided by total nationwide employment.) Hiring has essentially fallen off a cliff over the last year and a half. It’s far lower than it was during the 2001 recession.
Now consider this chart, which shows the rate at which companies lay off workers:
Layoffs have clearly soared in the last six months. And the layoff rate has been high for longer in this recession than it was in 2001. But it has not hit a new peak. It’s merely tied its old peak. The layoff rate was roughly the same in March 2009 as it was in March 2001. (Unfortunately, these numbers exist back to just 2000, but another survey suggests the peak layoff rate in the 1990-91 recession was at least as high as the current rate.)
You don’t see these numbers on hires and layoffs very often. The much better known statistic is the net number of jobs added or lost, which comes from the Labor Department’s monthly employment report. The most recent report showed that 539,000 jobs had been lost in April. This net number is the difference between the hiring and layoff numbers, along with a couple of other categories, like the number of workers who quit their jobs.
Imagine, for example, a company that has 100 workers at the start of the month. If it lays off 6 of those workers and hires 5 new workers, the monthly employment report will show a net loss of 1 job. But the turnover survey will show the details behind that net loss: 6 layoffs and 5 hires.
When people talk about the enormous job losses of the last year, they tend to assume that job cuts are the main reason. But these turnover numbers tell a clear story: layoffs aren’t the main problem. A lack of hiring is.
Why? How should the government respond? How should the country’s long-term economic policies be changed to reverse this long-term decline in hiring? All are good, hard questions.
It’s hard to see how we’ll find the right solutions if we are misdiagnosing the problem.
http://economix.blogs.nytimes.com/2009/05/15/layoffs-arent-the-main-problem/?hp
HGSI
Looks like an interesting buy at these levels. I'm not sure whether I should get in now or after the Lupus trial results.
OT Roubini
I wouldn't be so dismissive of his predictions. While he may be too bearish this rally makes no sense. Moreover I disagree with most people that in this recession unemployment is a lagging indicator. In fact rising unemployment will exacerbate this crisis since it will lead to more foreclosures, more credit card defaults and less consumer spending. This is turn will lead to more losses at banks and therefore less lending leading to more job losses and the cycle continues. I agree with Krugman. There needs to be massive spending by the government to stem job losses. That's the only way out.
BTW if the 72000 census jobs were disregarded, the decline in non-farm payrolls would be 611,000 which would be slightly higher than estimates. I think the only reason this number wasn't higher was because inventories were low. Once inventories reach higher levels there will be more layoffs. Chrysler and probably GM bankruptcies will have consequences for job losses in the coming months. If federal spending doesn't lead to increased hiring soon this will all head down hill again. Also keep in mind that gas prices are increasing again and this will probably lead to decreased consumer spending and higher transportation costs than 3 months ago.
Matt Harper obviously missed DSCO's 4th denial by the FDA.
DNDN offering price
Anyone know what the price is? Not specified on the release. How does that work out.
Well I assume the contracts were written after insiders became aware of IMPACT results (doesn't make sense for them to do it before unless they were so confident in the result) but if that's the case they were probably aware of the quarterly results. The equity financing was probably done after the IMPACT results were announced so that should be ok.
VNDA
Amazing. Who would have thunk it. Did the possibility of the company being liquidated and the drug being abandoned drive the FDA to approve it with a strong warning? The about face is remarkable.
DNDN insider sales
Obviously the sales were pre-existing but i've been wondering when the contracts were written. Don't recall too many sales right before a 10Q release.
DSCO - There is no way this current management is ever going to get approval from the FDA. The inability of management to realize what the FDA requires after 3 attempts and the fact that the FDA has questions that seem serious enough to delay the launch of this product by a few YEARS due to manufacturing issues, shows the complete incompetence of management. The FDA should be concerned about what would happen to the product even after approval if management is so incompetent. Can they trust management to ensure that the product would be reliable in the future? I think the answer is no. DSCO has to sell itself.
dndn and shorts - The shorts have arguably helped elevate the share price. If there wasn't a short squeeze would the share price have reached the levels its at now. In addition shorts helped keep the share price low so that people who knew the drug was probably going to work could get in. Its a pity that the short interest was actually down since 2007 because we could have seen a higher jump in share price due to the squeeze.
dndn - i'm curious why the fda submission is almost 8 months away since new data would be just an amendment? If the data is ready whats preventing them from submitting a couple of months after the conference?
DNDN - This is great news for cancer patients. I wonder how this would affect future FDA decisions especially WRT to drugs that cure terminal diseases. A conditional approval 2 years ago could have saved many lives.
dndn -
Didn't 9901 fail the primary endpoint of slowing disease progression? I hope the results are good but 9901 is not a good precedent methinks.
* Drug for premature infants has big sales potential
* FDA has not questioned effectiveness of Surfaxin
By Ransdell Pierson
NEW YORK, April 9 (Reuters) - The chief executive officer of Discovery Laboratories Inc said on Thursday his company's experimental drug, Surfaxin, could displace rival products used to treat a dangerous respiratory condition in premature infants.
"With proper partners in the future, Surfaxin has potential to be revolutionary in nature" and to generate blockbuster sales, Robert Capetola said in an interview.
The U.S. Food and Drug Administration is expected to make a decision by April 17 on Surfaxin, a coating designed to help the lungs of premature babies properly inflate and deflate. Many preemies require ventilation equipment because their lungs have inadequate natural lung coating, called surfactant.
Surfaxin combines three types of fats with a humanized protein -- meaning one that has the same arrangement of amino acids found in natural human surfactant. In clinical trials, it has reduced mortality in preemies compared with currently available pulmonary surfactants made with cow or pig proteins, or with fats alone.
The tiny company has been developing Surfaxin for 11 years, and has failed on several occasions since 2004 to win U.S. approval.
Capetola is hoping its latest marketing application will be the charm and noted the FDA has not questioned the effectiveness of Surfaxin. Instead, he said the agency has wanted to ascertain that manufacturing and purity standards were followed.
"We've addressed all their questions in what we consider a very satisfactory way," said Capetola, a former head of discovery research for Johnson & Johnson .
Tom Miller, Discovery Labs' senior vice president of commercialization, said current pulmonary surfactants now have annual U.S. sales of about $75 million and that Surfaxin could make them obsolete.
"Our goal is not to fight for limited market share, but to completely displace animal-derived surfactants," he said. "Globally, current products have annual sales of $200 million and we expect to eventually own that entirely."
But he noted that no clinical trials of Surfaxin have yet been started in Europe or Japan. (Reporting by Ransdell Pierson; Editing by Andre Grenon)
http://www.guardian.co.uk/business/feedarticle/8448248
dsco
Discovery Labs says Surfaxin could displace rival drugs
04.09.09, 03:45 PM EDT
pic
April 9 (Reuters) - Discovery Laboratories Inc:
* Says has addressed all FDA questions about surfaxin as it awaits April 17
agency action on drug
* Labs CEO says FDA has not questioned effectiveness of its surfaxin lung drug
for premature infants
* Labs CEO says surfaxin has blockbuster sales potential
* Labs says aims to completely displace animal-dervived surfactants that now
have annual u.s. sales of $75 million
* Labs says its product deserves 'premium' price, given superiority
* Labs aims to eventually 'own entirely' the global market for surfactants
* Labs says would need to hire 30-40 sales reps for U.S. surfaxin launch
* Labs CEO says confident in company's financial cushion
* Labs says more willing to partner surfaxin, given general economic
environment
* Labs says Johnson & Johnson already entitledto licensing fees on
drug, would be a 'great partner'
http://www.forbes.com/feeds/afx/2009/04/09/afx6276420.html
I could have sworn they used the word PI during the call but I could be wrong
dndn lazard call
not that i recall but apparently the PI was not enamored with provenge and thats putting it mildly.
crme and mrk
seems like a huge risk given that astellas hasn't even responded to the approvable indicating that there are serious issues with the inhaled version. I would imagine that MRK has done its due diligence and concluded that everything was tip top but then why the lengthy delay for the response?
Also if astellas was going to submit soon crme would have waited a little while longer to increase their leverage it seems to me.
Lung drug approval key for cash-strapped Discovery Labs
* Analysts confident of FDA approval for lung drug
* Drug approval to help co secure funding
By Anand Basu
BANGALORE, April 7 (Reuters) - A probable approval of Discovery Laboratories Inc's experimental lung drug for infants could breathe fresh life into the cash-strapped company, ending "going concern" doubts and opening doors to new funding.
Analysts expect the drug, Surfaxin, -- designed to treat a respiratory illness in premature infants -- to get regulatory approval by the current action date of April 17.
Washington, Pennsylvania-based Discovery Labs, whose auditors last month expressed doubts about its ability to continue as a going concern, had earlier said it was looking for additional capital through strategic alliances and equity and debt financing.
But a marketing approval for Surfaxin would allow the company to raise cash at more favourable rates from credit facilities, potential partners and capital markets. "The cash issue goes away upon approval. (It is) a serious issue if there is no approval," Brean Murray Carret & Co analyst Jonathan Aschoff said.
As of Dec. 31, 2008, the company had cash and marketable securities of $24.8 million, and has the ability to raise capital under its existing Committed Equity Financing Facilities to support its business plans.
Net cash burn for the fourth quarter of 2008 was $6.7 million.
Wedbush PacGrow LifeSciences analyst Kimberly Lee said new capital would also be needed to launch Surfaxin.
She said the company does not have enough cash to fund operations beyond the second quarter, and the possibility of any partnership remains bleak until Surfaxin gets approval.
Discovery Labs has been trying to get Surfaxin approved as a treatment for respiratory distress syndrome (RDS) since April 2004, but has been asked thrice by health regulators to submit additional data and resolve issues about the drug's chemistry and manufacturing.
According to the National Heart, Lung and Blood Institute website, RDS affects about 10 of every 100 premature infants, or about 40,000 babies, in the United States each year.
ISSUES RESOLVED
"I think the drug is efficacious and safe, and it should be approved, based on that and the unmet medical need. However, the execution risk remains, because it's already gotten three approvable letters," Wedbush PacGrow's Lee said.
Analysts said the company had earlier refrained from giving clear information publicly about the issues that were raised by the U.S. Food and Drug Administration in its earlier approvable letters.
"We didn't know about a lot of these (issues) in the approvable letter before," Lee said.
However, in its second and third new drug applications, the company detailed manufacturing problems and the stability of the drug.
"I think they have finally addressed all the issues. They publicly said what the issues were rather than being vague about it," Brean Murray's Aschoff said.
Discovery Labs has also finalized Surfaxin labeling discussions with the FDA, and the regulator has completed its pre-approval inspection of the company's manufacturing facility in Totowa, New Jersey.
Analyst Lee, who has a "hold" rating and a price target of $3 on the stock, sees peak sales of $45 million from Surfaxin by 2012, while Brean Murray's Aschoff, who has a "buy" rating and a price target of $3.50, expects sales of $17.5 million in 2010. (Editing by Vinu Pilakkott)
http://www.forexpros.com/news/commodities---futures-news/analysis-lung-drug-approval-key-for-cash-strapped-discovery-labs-43031
DNDN
If reduction in risk of death is say 18-20% instead of 22% does the FDA approve it?