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HDGabor

06/20/19 1:06 PM

#197762 RE: MedResCollab #197758

M-

accurately conveys the preliminary notification of an AdComm from FDA in the 74-day letter

Looks like you missed the relevant part in the "74-day letter"

the FDA did not indicate whether it plans to hold an advisory committee (AdCom) meeting to discuss this application

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sharinky

06/20/19 1:14 PM

#197766 RE: MedResCollab #197758

You probably should have actually listened to what the company has said since they would have received the 74 day letter. You need to retract the other part as well. From June 12th - "Again, we’ve heard neither yay nor nay on that topic that will silence at this point time and again that’s not surprising."