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sharinky

06/26/19 7:28 PM

#198654 RE: Yoyippie #198646

Though the FDA generally tries to adhere to PDUFA dates, they aren't set in stone, and it's not unheard of for the FDA to extend a PDUFA date. This generally happens when the FDA needs more time to complete the review process.

Biobillionair

06/26/19 8:16 PM

#198659 RE: Yoyippie #198646

The ramifications of moving the PDUFA date for Vascepa will gut CDER DMEP. I will move to eliminate the DMEP and have already started the process today./-BB