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Ampio Pharmaceuticals, Inc. Message Board

  • ed_007_v2 ed_007_v2 Jul 2, 2012 1:24 AM Flag

    Interesting times for Ampio (part1)

    Optina is coming up for discussion in a pre-ind meeting with the FDA. I assume it will be for discussion of a phase II trial in the US. The sample size was so small on the Canadian trial that I can't imagine anything else. However, that small sample size was still statistically significant in one arm. To me, that means the drug works. A larger US Phase II trial will tell more about how well. That is one part of getting FDA final approval. The second part is safety. On that point, this drug has been on the market since the 70's-- being used at around 10 times the dose Ampio is using. A small dose could have safety issues that a larger dose didn’t. But that seems unlikely. Because of the humanitarian aspects and the potential cost savings I believe the FDA may be receptive to expediting the trials for this drug.
    Even though it is repositioned drug, because of the small dose, Ampio was able to get a 20-year patent on Optina. And that happened just this year. Usually many years of the patent life have expired by the time a drug reaches this stage. That makes Optina more valuable in relation to its market size than is normally the case.
    Because Optina works systemically it may also perform equally well on kidney and other health problems associated with diabetes. If the safety profile is good, as I expect, then this drug could be used in a preventative manner. Ampio has said that CRO has not yet released the data on Optina’s effects on the kidneys. WATCH FOR THESE FINDINGS. They should be out very soon. Positive results would be a big incentive for Optina to be used as a preventative drug instead of as “just” a treatment for DME. At that point it could save Billions in other diabetes related treatment costs. It would still be a very valuable drug as a treatment for DME if not, but I think the case for the larger potential should be made also.

 
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