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Biobillionair

06/06/19 2:29 PM

#195536 RE: veteranseabee #195523

Vet- Thanks for pointing out the article, here’s a quote from Dr. Woodcock that stands out:

"We have accelerated approval for a reason," Woodcock said. "It wouldn't be accelerated if it has the same results as regular approval."



It seems Woodcocks views priority reviews as a tool to get patient helpful drugs ASAP; damn good sign Vascepa gets approved well before September 28th. The likelihood of an Ad Com or CRL are very very slim after the FDA has applied the resources. Remember Jenkins is gone and Woodcock is doing both positions now.

BB