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sharinky

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sharinky

Re: KCSVEN post# 212308

Tuesday, 09/03/2019 12:45:23 PM

Tuesday, September 03, 2019 12:45:23 PM

Post# of 425619
If the reason for the delay is because the FDA failed to schedule the AdCom appropriately, the PDUFA date will not change. The PDUFA date is a guideline that the FDA will fail to meet.
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