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baltimorebullet

02/12/21 8:01 AM

#298474 RE: vg_future #298423

He speaks of Rett approval/revenue as it were a given(as did Dr. Randi Hagerman).
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Kmadd

02/12/21 8:12 AM

#298479 RE: vg_future #298423

Yes, Rett approval seems imminent, especially in Australia. The language around the trial extensions of 6 month, compassionate use and 100% patients seem to center around needing to submit final packages and needing time for agency approvals.
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nidan7500

02/12/21 8:25 AM

#298487 RE: vg_future #298423

There are going to be a lot of soiled diapers on WS and BP when they finally begin to understand what AVXL is all about. AVXL and some others are redefining what the FDA's job is along w/NIH and most of the Big Academic Boys/Girls who have controlled money and who sits at the table.

The other good news is, there is little evidence BP even understand that their organizations/structure/resources and infrastructure are being made obsolete while they missed the train. IMO, Dr.M. is happy b/c he cannot believe the BP competition does not even (YET) understand they are toast.

The old street expression..."if you think I did not cut you, try to move your head". Comes to mind.

Priceless. BTW, anyone familiar w/FDA and how they do change will agree it will take decades for them to reconfigure. Hint, the 5 year trial process is dead/non competitive. Bury it and move on. Find a way to get it done in one year.