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Re: no2koolaid post# 218221

Wednesday, 07/27/2016 2:41:34 PM

Wednesday, July 27, 2016 2:41:34 PM

Post# of 403670
Lets hope ELTP gets approval next time


As for the thought that the FDA might delay approval...as a matter of effective decision making and organizational function, the FDA would have notified Elite and Elite would have had to PR the delay. Since, according to more learned people in the field of FDA watching, the FDA generally notifies the applicant (in this case Elite) of their decision 3 days prior to the PDUFA date, so as to allow them time to create a proper a PR. And, we are 3 days from that date...

The evidence is clear and decisive, born of past practice by the FDA, Elite will receive approval for SequestOx on or before July 14th (three days hence) AND WITH THE ALL-IMPORTANT ADF LABEL.


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