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Biobillionair

09/03/19 5:14 PM

#212358 RE: sharinky #212351

Shar-

Nothing, the FDA would miss their deadline, as they should, if this is their fault.



Not approving Vascepa for an at fault missed PDUFA date will kill cardiovascular patients, do you recommend DOJ file charges?

BB
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Biobillionair

09/03/19 7:25 PM

#212383 RE: sharinky #212351

Sharinky- FDA doesn’t get this both ways...if they miss the date it is their fault.

"So what would happen on PDUFA date? " Nothing, the FDA would miss their deadline, as they should, if this is their fault.



So does the intentional miss get prosecuted.... if so this would be First degree intentional homicide or some diluted manslaughter charge....?

You made a great point with at fault missed PDUFA date...how about your follow up opinions on FDA “at fault “ accountability for actions and inactions?

Thanks

BB