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Ampio Pharmaceuticals, Inc. Message Board

  • wolfmanran wolfmanran Aug 21, 2014 8:51 AM Flag

    If the results are good, then ...

    why not petition the FDA to approve the drug, with the requirement that the drug is frozen first before ingestion by the patients. Then do a followup study for a non-frozen procedure?

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    • The company would not know yet if this has affected their study. Dissecting their wording I read that low temperature may affect efficacy and that is where the market will react. At

      Sentiment: Strong Buy

      • 1 Reply to truont2
      • less 0 C what happens to the drug? When the drug is returned to 15 C, what's the remaining active yield? Is it 60-90? If so, you can trend the results and build off of STEP to see what predicted would be. Not a total disaster considering we know what the multiple injections studies reductions are. Physicians will only be looking to the multiple injections for their patients. AMPE already stated that the FDA is willing to examine the STEP study (I suspect they looked at stability data) and were still fine with the trial. I expect STEP to be slightly lower than SPRING results but with the caveat of temperature affecting the % of actives given to patients.

 
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