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Re: mouton29 post# 117280

Wednesday, 03/30/2011 2:27:57 PM

Wednesday, March 30, 2011 2:27:57 PM

Post# of 257253
I agree with zipjet, which is something that does not happen around here every day :- ) Peptimmune filed its CP on 10/4/10 (#msg-55116264); 180 days from 10/4/10 is 4/1/11 (this Friday), so the FDA had a statutory requirement to respond to Peptimmune in the next two days.

Bottom line: I would not draw any inference about NVS/MNTA’s Copaxone ANDA or MYL’s Copaxone ANDA from the timing of the FDA response to Peptimmune.

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