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Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: IRWIN JAMES FRANKEL who wrote (2476)	9/7/2010 4:19:52 AM
From: idos	Read Replies (3) \| Respond to of 3027

IJ, agreed that by statements such as "A finding of sameness does not, however, necessitate a finding of "complete chemical identity."" (from that letter to Teva), the FDA indeed opened the door and is as you wrote - willing to look for a robust suite of data to show "sameness", and evaluate the data with an open mind. This is a gig step forward, but I think that without knowing exactly how the drug acts and without an in vivo/in vitro assays (unlike with Lovenox), it is going to be extremely difficult for anyone (even as sophisticated as Momenta) to show "sameness" and a clinical trial will be needed, imo. So much for the regulatory hurdle, now it's time for you lawyers to review the legal issues :)