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corpstrat

02/19/08 12:02 PM

#3336 RE: exwannabe #3334

I like another man (person) who's willing to wear the cap if it fits. But there's no IND issue for the UF and Endo studies - their INDs were agreed long ago.

If you go back to the discussion when JP announced that FDA wanted a new IND for anemia, nobody has come up with a good raionale, beyond "sometimes they ask for this, others they don't." It's most likely taste and fancy. And the FDA team IS worried that Proellex works so well that women will use it in long-term indications before safety is checked out. Maybe they convinced themselves that requiring a new IND would help ward that off, though of course it's the FDA's response to the NDA that will do that.

Now if only I could believe that the FUD around this IND is what is making money hard to raise for RPRX (the only real snag about Mr Market's idiocy), so that when it is dispelled the money problem will go away. Alas, not likely. But perhaps the 2/28 presentation in florence will get us closer to acceptance that Repros did not simply cook up all the great data.