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Affymax, Inc. Message Board

  • godwinpeak godwinpeak Sep 11, 2013 4:38 PM Flag

    Good Question: How Many Adverse Reaction Reports Should It Take?

    From a Fierce Pharma article:

    In February, FDA announced a recall of all Omontys lots, citing reports of serious reactions, including three deaths. As the WSJ notes, the adverse event reports to FDA included 12 deaths in patients using the drug, but it's uncertain whether Omontys actually caused them. Takeda itself weighed 5 deaths in deciding whether to pull the drug, the Journal says....

    The question the WSJ report implies is whether Omontys should have been suspended last fall, rather than in February. Affymax was worried enough in October to ask for the labeling change [to warn of anaphylaxis], and that was before Omontys went into broader use at Fresenius and other dialysis centers. How many adverse-reaction reports should it take?

    AFFY longs are like Hilary Clinton: "What difference does it make?" Apparently none at all. AFFY longs believe they have a winner in O, and everybody is anxious for its return to market as a "blockbuster"!

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    • Counselor you continue your unsuccessful setup pattern. First you declare the question that follows to be a good one. Second, in keeping with your well established slick tactics, it turns out that the question itself, because it is based upon a lot of different opinions (NOT FACTS), and, therefore, without merit makes your lead in comment a lie. The "More" is therefore not worth reading. Son, when are you going to get a brain?

      Sentiment: Strong Buy

    • O is coming out after the investigation is done. I've been speaking with takeda. No time to say. Can be 2-11 months

      • 1 Reply to curtis_238
      • Curtis, there is no way that from the scripted, ambiguous responses Takeda offers to current and potential investors that you could say definitively that you know when everything is going to be resolved. Saying anywhere between 2-11 months is like forecasting snow between 2-11 inches. The window is so big of course you have a chance of getting it right. But that is going to do nothing for your credibility. Posts like these are equally dishonest and irresponsible as the disingenuous short theses that are fed to us.

    • You keep neglecting to mention that O worked fine until Fresenius got ahold of it.

    • Seems like a tremendous amount of effort being expended trying to drive down the price of a stock trading around $1.50 a share. Short covering over the last 3.5 months has taken down the short interest by about 60%. Why didn't they stay around if BK was imminent? Why did the Brennar Group take the company down to the bare bones so it could survive instead of not wasting the time and effort and declare BK? Move on to another restructuring? Why restructure existing agreements and pay down debts? The lawyers are awaiting the results of the investigation to determine culpability of the company, the drug, the clinics, the administration et al. The longer this goes on the greater chance that the company can survive and the possibility of bringing the drug back is greater than 50/50. Everyone should know this is highly speculative, but trying to pitch for pennies on the short side, when dollars have already been made seems rather silly. Other opportunities exist elsewhere. The longer time goes on the odds favor the long side rather than the short, because as you and others have stated repeatedly BK is just around the corner any minute now. At this point it is like waiting for Godot.

      • 1 Reply to pbjorkl904
      • Interesting take. All AFFY SEC disclosures I have read seem to say that Takeda needs to identify and rectify O's safety issues quickly and in the near future, or AFFY cannot survive. My view is the longer the process takes (and AFFY says it may be lengthy), the less likely it becomes for AFFY to survive. Even The Brenner Group has warned that with the AFFY restructuring "substantialy complete", there is no guarantee that AFFY will not go bankrupt.

    • Why don't you tell us about the FMS letter that prompted you to short all you could. The one before the recall.

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