Replies to post #117300 on Biotech Values

[jb_118]

Re: MNTA Copaxone review timing.

Although I would remind us that Wheeler was very conservative in his last conference call in managing down expectations about FDA timing. He noted it is going much slower than mEnox, and while it is moving forward, they wish it were going faster. My completely subjective WAG was guiding towards the end of the year or even into next year rather than 1H 2011.

[mouton29]

<<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.>>

Well, I accept that the FDA had to respond in the next couple of days. But they could have said, we have not made a determination yet and stopped with that. Instead they said, we have not had an opportunity to fully view information and data submitted. Presumably they have to first review the data and then it will take some time to masticate, ruminate and debate said data. On the other hand, this could be semi-boilerplate from the FDA, the equivalent of language in a answer to a complaint.

I think I will go sell me some call options as I don't think approval is imminent. ;-)