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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: idos who wrote (2475)	9/6/2010 8:49:38 PM
From: IRWIN JAMES FRANKEL	1 Recommendation Read Replies (1) of 3027

>>However, the problem as we have all noted is the last criterion. I cannot appreciate the task that MNTA has to show "sameness" to the FDA on Copaxone (nor L). It is now clear that "sameness" is not an identity. I also find it interesting, and think it now clear, that the FDA is willing to look for a robust suite of data to show "sameness", and evaluate the data with an open mind. If they perceive weakness in the data they will describe it and look for additional data to create the overlap that convinces them for or failing which, against approval. I will leave the science to those of you who understand it. But it sure looks like FDA is open to being convinced that Copaxone can be copied reliably. This is a huge opportunity for MNTA. ij

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