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pollyvonwog

11/07/12 12:24 PM

#151886 RE: DewDiligence #151876

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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DewDiligence

11/07/12 8:21 PM

#151905 RE: DewDiligence #151876

MNTA—Is there a more promising biotech company with an enterprise value of $275M or less (#msg-76922372, #msg-81239852)? If so, I’d like to know what it is.