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Re: Jonjones325 post# 188407

Friday, 04/05/2019 8:12:03 PM

Friday, April 05, 2019 8:12:03 PM

Post# of 464401
Great summary Jonjones. You even got the side quotes, as if you were there.

your brother came loaded for bear, asked a lot of good questions.

Only thing I might interpret differently:

Someone asked if there would be another trial after the phase 2B/3. Missling stated that this one is our phase 3 not a pre-phase 3. I’m taking that to assume that no other trial would be needed afterwards.

I took this a bit differently. Dr. M said a 2B/3 is a p2 trial structured to the parameters of a p3 trial. So yes in terms of quality it is exactly what they would run as a p3, including large sample of 450. As whether govt thinks that way, Missling would like them to take it as such, and got directly to P4 with accelerated approval, but he was very conservative in setting expectations by saying FDA could require p3 because so many people would take this drug, huge market.

NO discussion of 371 for those who asked.

You have to ask yourself, "Do I feel lucky?" Well, do you short punk?

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