Replies to post #156770 on Biotech Values

[DewDiligence]

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.

Respectfully disagree. The FDA is well aware of the CAFC ruling in the Amphastar case and the harm it could do to the generic-drug/FoB industry if not overturned. Hence, when it comes to generic Copaxone and FoB’s, the FDA will not publish the kind of detailed roadmap for competitors as they did in the reply to SNY’s Lovenox CP.