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Thursday, April 06, 2023 3:03:10 PM
How could they not have met the COMBINED ENDPOINTS. If the low 30mg dose did not meet the goal then the 50mg must have blown it away the primary endpoints. If they both did not meet the end points then they could not say that they met the endpoints And it would not make any sense if the 30mg did better than the 50mg. So tell me how they get to announce that they hit the endpoints and you come here saying that they didn't.
The Primary endpoints are as follows:
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
ADCS-ADL (Activities of Daily Living) [ Time Frame: 48 weeks ]
Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL).
Now maybe they didn't hit all the Secondary like they stated. But some of them they hit.
Secondary Endpoints:
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Also remember, Alz approval is a low bar. Biogen was horrible for patients. At least we see some improvement with our drug.
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