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Ampio Pharmaceuticals, Inc. Message Board

  • sirmichael222 sirmichael222 Mar 12, 2013 12:53 AM Flag

    My opinion: No Zertane approval yet by FDA

    My opinion on Zertane is the following: People are talking as if the approval of a participant questionnaire means that the FDA has approved Zertane, the drug itself. The FDA has not done so. The FDA has merely given approval to the form and wording of a questionnaire on which each participant will put his responses to questions about his trial use of the drug. Let's get real; the truth is that the drug may never get FDA approval. I certainly hope that it will, but it may not.

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    • sirmichael..,. you are 100% correct. However, I think the excitement (in everything except the stock) comes from the following:

      1. Zertane has already undergone 2 successful phase III trials (Australia) and thus shown to be effective
      2. The drug has no safety concerns
      3. The FDA has never previously established any kind of standard by which to measure a PE drug, and thus has never approved one
      4. The FDA's approval of the questionnaire was/is the biggest challenge facing approval of Zertane in light of #1 and #2 above
      5. Ampio apparently "owns" the rights to the only approval criteria for a PE drug (Interesting, although I would expect that others - J&J? - could come up with their own questionnaire)
      6. Ampio's statement that a partner deal was imminent pending approval of the questionnaire by the FDA.
      7. The drug could be bigger than Viagra (PE is more prevalent than ED)

      But yes... you are correct that Zertane has not been approved - yet - and anything can happen.

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