Dear New World Investor:
There are bull markets, bear markets, and now an Energizer Bunny market. The S&P 500 just kept pressing higher bit-by-bit, but I really though we needed at least a little breather. After yesterday’s Fed decision, there was a brief spike up to 1080, a new recovery high, that used up all the short-term energy. The S&P fell back to 1060 at the close, and I was glad to see it dip down to 1045 intraday today , which was
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Amgen, Arena Pharmaceuticals, Clinical trial, Dendreon, Health, US Food and Drug Administration, Weight loss
BioCryst Gets Phase III Funding & First Stockpile RFP
BioCryst (BCRX) announced this morning that the Department of Health & Human Services has agreed to provide an additional $77.2 million to complete the Phase III trials for peramivir. This contract modification extends the four-year contract to five years, and brings the total award to $179.9 million - without any shareholder dilution. The bears and paid bashers such as BioLogic have been pointing to the lack of additional funds as a huge negative that might require a large dilutive stock offering. This contract extension puts their FUD (fear, uncertainty and doubt) to rest. Of course, there was never any question that HHS would pay for the trials, the only question was how much.
The FDA to their shame still has not issued an Emergency Use Authorization, but Health & Human Services (HHS) gave BioCryst a sole-source Request for Proposal for 1,000 to 40,000 courses of treatment to be used in the ICU. A standard course of treatment is five doses of peramivir. All of the bears and some of the bulls keep confusing doses with courses – this RFP is for 5,000 to 200,000 doses. I have been estimating a very conservative
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BCRX, BioCryst, Clinical trial, Federal government of the United States, Health, India, Influenza, peramivir, Southern Hemisphere, United States Department of Health and Human Services
BLOSSOM Trial Results Hit All Targets For Arena
Lorcaserin Will Be Approved By October 2010
Arena Pharmaceuticals (ARNA) issued their press release on the BLOSSOM Phase III clinical trial results early this morning, and the results were good. Basically BLOSSOM essentially matched BLOOM in every respect, including the all-important heart valve safety data. We’ll get more info from the company’s presentation at the Obesity Society meeting in Washington, DC from October 24 to 28. Arena plans to file their New Drug application in December, so the PDUFA date for an FDA decision should be in October 2010, ten months after the filing.. There probably will be
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Anti-obesity medication, Body weight, Clinical trial, Contrave, Fen-phen, Health, lorcaserin, Qnexa, US Food and Drug Administration, Weight loss
* * * ARENA TO PRESENT BLOSSOM DATA TOMORROW 8 AM – DETAILS BELOW * * *
Dear New World Investor:
Stocks rose sharply yesterday, with the major indices hitting more new intraday and closing highs for the rally since March 6. Let’s have a moment of silence for those who “sold in May and went away.” You might also want to go back to late August/early September and read all the helpful articles on how September is the worst month of the year. To be fair, the first day of September was nasty. But that was it, and the S&P is working on its seventh straight month of gains.
With the S&P 500 clearing my 1060 target with ease, it looks like the next stop for this train is
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Anti-obesity medication, FDA, Health, Obesity
