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Couch

04/07/17 4:47 AM

#249978 RE: jour_trader #249975

I don't think that is the case but I easily could be wrong on this one. My read is that regardless of the ER drug - bc of the timing of when you take the drug and length of the drug in your system - the FDA has not made an issue of the TMax with any ER drug. That would go for Elite, Purdue, Pfizer or Inspirion or any other company.

I believe Nasrat, in this case, was speaking to why IR drugs are more tricky to get approved than ER drugs regardless of IR product or company. I heard Nasrat saying Elite was not unique here. I thought he did convey that could change but he did not expect the FDA to harp on the TMax situation with ER drugs across the board and that was with all companies. Again, maybe I misunderstood this.