News Focus
News Focus
Post# of 257257
Next 10
Followers 20
Posts 2057
Boards Moderated 0
Alias Born 06/14/2007

Re: DewDiligence post# 156729

Monday, 02/11/2013 10:47:46 AM

Monday, February 11, 2013 10:47:46 AM

Post# of 257257

it’s reasonable to assume that the FDA will be less revealing of the methods used by ANDA applicants in light of the CAFC ruling in the Amphastar case.



I agree with your point about MNTA's trade secrets, but I'm not so convinced the FDA will be less revealing. If/when they approve m-copax it will be too quite some fanfare and I'd imagine the FDA will have to be equally as thorough (and revealing) in their reasoning as they were with enox.

Trade Smarter with Thousands

Leverage decades of market experience shared openly.

Join Now