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HerbieRay

06/26/19 3:59 PM

#198621 RE: Biobillionair #198620

BB

So why didn’t the FDA communicate with Amarin? Because there’s bad blood between the two due to past legal issues.

I have requested an explanation yesterday, got nothing.

Today I requested the Senate HELP send a direct letter to Dr. Woodcock to clarify why PDUFA goal dates are being arbitrarily ignored regarding Vascepa application.



You are making an assumption based on your perceptions and personal resentments. You are owed nothing and will probably get nothing back.

Wants the difference anyway? By Oct 1st this will all be moot.

Relax and Enjoy the ride.



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KCSVEN

06/26/19 4:02 PM

#198622 RE: Biobillionair #198620

Pretty sure those are guidelines they shoot for not rules, a quick Google search you'll find 30 days notice of AdComs so 55 days is not set in stone.
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rafunrafun

06/26/19 4:02 PM

#198623 RE: Biobillionair #198620

BB - The 55 day thing that you mentioned is BUSINESS days, not CALENDAR days, which puts the latest day possible for the announcement way before June 28.

But I think that is more of a recommendation than a set (unbreakable) rule.

If that was a set rule, Thero would not have said that there is still a chance for an AdCom.
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Yoyippie

06/26/19 6:12 PM

#198646 RE: Biobillionair #198620

Somebody posted that the PDIFA date is also flexible. If they want an adcom sept. 1st the. The pdufa date then gets bumped the 55days. Not sure the truth to the post but just sayin. Please don't ask for a link