Replies to post #117280 on Biotech Values

[anotherbiotechguy]

Seems to all bode well. Peptimmune filing for Chapter 7, prior arrangement with Novartis, etc.

[zipjet]

This would seem to suggest that approval is not imminent, but I suppose there is no way to predict when they will finish their review.

I would not say it that way. Clearly FDA was under a time deadline to respond to the petition. Once that time was running out they needed to reply.

So I would argue the even another week and the decision not being final on a generic Copaxone could be the basis for what they did.

There is no advantage to FDA reciting their decision until it is final.

JMHO

ij

[DewDiligence]

I agree with zipjet, which is something that does not happen around here every day :- ) Peptimmune filed its CP on 10/4/10 (#msg-55116264); 180 days from 10/4/10 is 4/1/11 (this Friday), so the FDA had a statutory requirement to respond to Peptimmune in the next two days.

Bottom line: I would not draw any inference about NVS/MNTA’s Copaxone ANDA or MYL’s Copaxone ANDA from the timing of the FDA response to Peptimmune.