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Message Boards Settings Pain Therapeutics, Inc. (PTIE) - Quote Info
Launch of New Safer Oxy is win/win for Remoxy      8-Nov-09 04:47 am    
BM of King at their Q3 CC says that he believes that new safer Oxy will be launched at some stage. He said that the launch of the new safer Oxy is a win/win situation for Remoxy. The launch of the new safer Oxy will stave off generic Oxy competition and will be positive for the 'value of the market place' (whatever that means). Purdue will be formidable competition but BM hopes that Remoxy will compare quite favorably with Purdue's formulation and that he will be able to prove that at the time when its launched. He thinks that Remoxy is a better formulation despite admitting that he hasn't yet had the opportunity to compare the two!

He also said that all new Remoxy studies are underway and everything is on track. No announcements will be made on the results of those studies prior to the resubmission of the NDA. He expects that there will be another Ad-Com meeting to discuss Remoxy prior to the FDA decision. He expects the FDA to review Remoxy expeditiously - he believes that the FDA will consider that there is still an urgency to review Remoxy quickly (like before).

He also said that on Acura they were carrying out a likeability study that he thought was important information to have for the Ad-Com meeting - not an FDA requirement. That sounds familiar. So I guess that the FDA doesn't need likeability studies but the Ad-Com does.

OK thats it - there were two Remoxy questions - the first was at about 21 minutes and he sounded pretty flustered - very unusual for BM.
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fgnoms

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Launch of New Safer Oxy is win/win for Remoxy
fgnoms Not rated 8-Nov-09 04:47 am  
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Pain Therapeutics Inc. (PTIE)

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