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pollyvonwog

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pollyvonwog

Re: DewDiligence post# 151876

Wednesday, 11/07/2012 12:24:27 PM

Wednesday, November 07, 2012 12:24:27 PM

Post# of 257580

Momenta expects to submit the first IND (Investigational New Drug) application in 2014 for its lead biosimilar, M923



So how will this work exactly? They submit the IND and then the FDA tells them where to go from there I take it? Best case scenario is FDA lets them skip all the trials? Or should we assume at least some degree of trials... Best case scenario, 2016 kind of thing?
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