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Re: pcrutch post# 145333

Thursday, 07/12/2012 8:08:08 AM

Thursday, July 12, 2012 8:08:08 AM

Post# of 257364
pcrutch...

Sorry to appear irreverent..(ask DD about that), but after a good nites sleep and going back over the FDA procedures...I have concluded, there is almost no chance this meeting was about the NCE desision...The FDA and more to the point the CDER make the NCE decision completely independent of the NDA applicant and would not be "tipping them off"..not be listening to their pleas...

The most likely reason for the OB "discussion" is the number and complexity of AMRNs patents, which have to be listed correctly in the OB, plus the likelyhood one or more enities (eg. Machita) might already have sent papers to the FDA...This would be a more suitable subject for FDA applicant discussion..

":>) JL


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