Momenta Pharmaceuticals Inc. Message Board

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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

0.0%

Oct 2 5:00 PM EST

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To: semi_infinite who wrote (2702)	1/7/2011 11:26:44 AM
From: tuck	Read Replies (2) of 3027

" . . . I am guessing the best Teva can hope for out of the meeting is we are still looking at it, more likely an approvable statement or letter." The former. Folks here still seem confused about the ANDA process. There is no "approvable" event as there is in the NDA process. There is acceptance or not of the application, which happened long ago. Then there is approval or not of the application. In the event of rejection, the FDA does not announce it; the applicant can if it wants to. Usually applicants just go back to the drawing board and try to address the FDA's action items without saying anything unless it is an obviously material event. Teva can arguably call a rejection of T-enox non-material, as earnings from it would be a small percentage of their total earnings. Now they've boxed themselves in and must say something by the time the FDA gets back to them, but I expect this to be a statement that the FDA is "still looking at it." Even if what the FDA actually tells them is that "we're done looking at it until you meet this, that, and the other requirement as measured by thus and so." Cheers, Tuck

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