SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?


To: semi_infinite who wrote (2973)6/25/2014 4:23:55 PM
From: DewDiligence_on_SI  Respond to of 3027
 
What's your opinion with regards to the influence of TEVA's legal maneuvers on FDA copaxone review? Seems that to me the FDA should have had plenty of time to evaluate the Sandoz/Momenta filing and that it should have been done by now if the data is adequate.
Teva seems to have succeeded at delaying the FDA decision to some degree by introducing the issue of gene expression. According to Court documents in the public domain, the FDA requested gene-expression data from MNTA about 2 months ago, and this is presumably the last item holding up approval.

Background: siliconinvestor.com ;
siliconinvestor.com

Regards, Dew