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Re: genisi post# 93029

Tuesday, 03/23/2010 3:34:23 PM

Tuesday, March 23, 2010 3:34:23 PM

Post# of 252713
Shall me move on to the next level of speculation on this matter? Assume this is not one of those times when you are wrong. What kind of trial would do the trick (I'm thinking large P1 or 2 trial would be enough)? How long would it take (someone here might remember off the top of their head how long it took Teva; if not I'll go dig)? Would there be enrollment challenges given the branded product on the market?

Momenta, with its first to file status, has deflected questions about its interaction with the FDA on generic copaxone. If someone directly asked them "We think there is a logical basis for the FDA to require trials. What do you think?" would we just get more stonewalling (likely, in my view)? OTOH, if the FDA had already signaled the need for trials to Momenta, would not this constitute a material event and require disclosure?

TIA & Regards, RockRat
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