Momenta Pharmaceuticals Inc. Message Board

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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: tuck who wrote (2952)	3/9/2014 2:27:56 PM
From: tuck	of 3027

Teva recently held a type C meeting with the FDA regarding differences between branded and generic GA. Their slides (hat tip to rwdm of IHub) go into considerable detail: Differences between branded and generic Copaxone As we've long known, the generics currently on the global market would not make the cut at the FDA. The safety issues noted with Probioglat are not unexpected by me, but I thought we would be seeing such data before now, given that other generics have been on the market for a number of years. This presentation does not, of course, include a comparo of the generics currently under review at the FDA -- unless Mylan really hasn't changed their version from the Natco product. It does make the hurdles look high, and may be the reason for recent weakness in MNTA shares. Cheers, Tuck

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