Replies to post #93037 on Biotech Values

[genisi]

Teva's latest trials are one small and few months long trial :
http://clinicaltrials.gov/ct2/show/NCT00947752?term=teva+song&rank=1
and one large and long:
http://clinicaltrials.gov/ct2/show/NCT01067521?term=teva+gala&rank=1
What will the FDA ask for? I'm guessing something in between - few hundred patients and couple of years long.

[DewDiligence]

MNTA:

If someone directly asked them "We think there is a logical basis for the FDA to require trials. What do you think?" would we just get more stonewalling (likely, in my view)?

This has been asked and answered on several occasions. The simple and direct answer is that the FDA accepted NVS/MNTA’s Copaxone application for review under the 505j (ANDA) regulatory pathway.

Since the whole point of the 505j regulatory pathway is to allow generic drugs to come to market without clinical trials, I consider the above answer a pretty good one.