Re: FRX, CYPB, and “close misses”
>Do you know of any examples of such drugs that were rejected with one good trial and one "just missed"? The only one I can think of is the imaging company but they are far from clear about what it is that they are measuring.<
I don’t know the answer, but I suspect that there were various clinical programs with a similar set of outcomes that were not submitted for approval. Even if you found all the similar cases that were submitted, the denominator of your fraction might be too small for the value of the fraction to be illuminating.
I stand by the common-sense answer I gave in the previous post: that the lack of preclinical data for treating fibromyalgia with Milnacipran will place a higher than usual burden on the clinical data. Regards, Dew
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