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KCSVEN

06/26/19 8:52 AM

#198540 RE: chas1232123 #198538

Not sure that makes any sense, maybe he meant 60 days before the PDUFA Date they need to have the Adcom by? If they gave Amarin 60 days notice on July 29 they would then have the Adcom on the day of the PDUFA Date?

Of course he adds "Practically speaking, it would have to be well before that. " so he's just doing simple math and trying to say if they have an Adcom before the PDUFA Date mathematically it mush be no later than 60 days before the PDUFA date.

It's kind of a dumb tweet because he ignores the need to have time from the Adcom to the PDUFA Date. And his 60 days notice for an Adcom is not supported by other Adcom's that have gone as little as 30 days from announcement to Adcom.

So to sum it up AF was drinking heavily before that tweet.

From our end I think the end of June is a solid cutoff, if nothing this week no Adcom seems pretty close to 100%. I guess theoretically they could announce July 15 for Aug 14 Adcom and be within the 30 days notice and about 6 weeks from PDUFA but seems unlikely they would make everything that tight and give notice that late.
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Yoyippie

06/26/19 9:18 AM

#198546 RE: chas1232123 #198538

AF came out earlier saying he is praying for an adcom so he can write about it.
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caddiedad

06/26/19 9:34 AM

#198551 RE: chas1232123 #198538

Isn't the September 28th day odd anyway (Saturday) and that's why he upped it a day early to Friday the 27th?
Would the FDA normally communicate business issues on a Saturday? That date has been a headscratcher the moment it was presented.
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SonamKapoor

06/26/19 9:57 AM

#198557 RE: chas1232123 #198538

Adam F. does this with a lot of his stories. The Vyleesi pre-menopausal drug just approved by the FDA - he said Monday afternoon the FDA shouldn’t have approved it and then pointed to management’s transgressions. Stat -Vyleesi. The stock predictably took a dive. I thought, “oh boy, bet he’s gonna write something like this on V day of FDA expansion approval and has the story already written.” I can’t remember which one, but he wrote a negative piece last Dec after the AHA Nov V negative article on another drug, too.

I realized then it’s his shtick and he’s sticking to it. He’s a bio-tech reporter who hates bio-techs. He reminds me of people who publicly hate on government and complain about it, but who work in government. It’s like biting the hand that feeds them.