News Focus
News Focus
Post# of 257262
Next 10
Followers 69
Posts 4516
Boards Moderated 0
Alias Born 12/13/2009

Re: dewophile post# 116132

Tuesday, 03/08/2011 5:54:34 PM

Tuesday, March 08, 2011 5:54:34 PM

Post# of 257262

if it does turn out that mylan starts trials



By trial, if you mean safety and efficacy trial required by FDA, it means FDA deemed Mylan's application CANNOT be processed via 505j ANDA. I believe Mylan will disclose it - MNTA will too. This is material information since both are in court challenging Teva Copaxone patent. Without disclosure, it would mislead investors that the application is still via 505j. On the other hand, if you mean bioequivalence trial, there isn't any consequence.

Trade Smarter with Thousands

Leverage decades of market experience shared openly.

Join Now