AI
Wednesday, March 30, 2011 3:13:12 PM
<<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.
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.
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