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Nerf

09/11/07 6:27 PM

#1421 RE: Bio_pete #1418

this is the crux of the problem imo, with androxal, and the retail understanding of the situation...

As long as the FDA says, for example, "study T, and FSH, and then come back with those results" then they can sell/partner the program. They can design and trial it.

If the FDA does not outline what they'd like to see, and leaves it up in the air, "we will look at your studies and then decide, you just study what you think is best" then there's no way for them to decide what they are going after, and more (most) importantly, no other company can put a value on the probability of success going forward.

Yes, that is the reason for the meeting, for the FDA to clarify their position on the drug and what they'd like to see it "proven" to do....