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Re: $heff post# 94120

Thursday, 05/26/2016 9:27:36 AM

Thursday, May 26, 2016 9:27:36 AM

Post# of 97237
No ADCOM is needed for SequestOx. ADCOM is a committee of 20 Pharma outsiders that the FDA may request IF it needs additional inputs. That time has past. The FDA and $ELTP have had considerable dialogue over the past 2 years concerning the HAL and 163 P3 Bunionectomy trial. Both the $ELTP HAL and P3 were very successful so that the FDA has all the info that it needs to make the SequestOx approval on its own WITHOUT the ADCOM. Look for SequestOx approval any day now as will be posted on the FDA Monthly/Daily approvals. Most definitely no later than the PDUFA of Jul 14,2016!

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