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| Alias Born | 01/31/2008 |
Sunday, March 20, 2022 4:47:17 AM
Good alz data = 1 trial accelerated approval
NO WAY will compelling data from our alz trial be held back from approval.
Australia will pull the trigger, maybe EU and UK also. FDA will fall in line.
Why?
Huge problem, no effective treatment, huge cost of alz care, aging population.
Plus the NDA will not just have P3 data, it will have OLE data from people taking it for years. Plus current OLE where half the P3 alz patients have been in the OLE for at least a year.
And Dr. Jill will clearly want it for the First Patient. As will the DC bureaucracy.
If 273 clearly works, no second P3 will be required. Bet on it.
NO WAY will compelling data from our alz trial be held back from approval.
Australia will pull the trigger, maybe EU and UK also. FDA will fall in line.
Why?
Huge problem, no effective treatment, huge cost of alz care, aging population.
Plus the NDA will not just have P3 data, it will have OLE data from people taking it for years. Plus current OLE where half the P3 alz patients have been in the OLE for at least a year.
And Dr. Jill will clearly want it for the First Patient. As will the DC bureaucracy.
If 273 clearly works, no second P3 will be required. Bet on it.
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