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Re: BonelessCat post# 66796

Wednesday, 03/27/2013 2:04:08 PM

Wednesday, March 27, 2013 2:04:08 PM

Post# of 146240
A PK/PD trial on only 40 patients would be cheap, and if it provided sufficiently unambiguous results to get Breakthrough Technology approval by the FDA that would be ideal. I assume that is NNVC's Plan A. But decisions like this have a high degree of capriciousness, it is a crap shoot. I and other investors must assume we will be stuck with Plan B, which would include full phase II testing followed by phase III testing. Now here is where I can agree with Puffer -- the cost of the phase III trials isn't really relevant, since phase III trials won't be done unless the phase II trials show clear signs of efficacy, and if they do, NNVC should have little trouble finding a partner to fund the phase III trials.

I am surprised by the cost of the Tamiflu trials. Of course we expect that Flucide will be unambiguously better than Tamiflu. It had better be, because obviously NNVC can't afford to do the kind of data mining that Roche did.
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