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Affymax, Inc. Message Board

  • seytrader seytrader Jul 1, 2013 2:20 AM Flag

    The paradox of small biotechs that set new standard of care:

    What do AFFY, PPHM And DVAX have in common? They were all denied the right to become de facto the new standard of care.I will assume that we all know about O. DVAX hepsaliv was supposed to take over from GSK Engerix for Hep. B. An FDA panel rejected the drug approval for safety reason because the trial size wasn't large enough to justify the safety of the vaccine (with respect autoimmune disease).Why did the FDA let the cie run such a small phase 3? PPHM bavi was supposed to be the standard of car in NSCLC by doubling the OS and PFS in phase 2.Unfortunately for PPHM someone at the cie that supervise the trial did identify a study coding error (between the patients in the control arm and the bavi arm) which created a doubt about the entire phase 2 result. It looks to me that it's very hard to beat big Pharma in the game of science only because they will get you somewhere else.

    Sentiment: Hold

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