InvestorsHub Logo
icon url

Anshu2

05/09/24 6:08 PM

#458712 RE: frrol #458654

Delay in talking with the FDA regarding AD seems to be: Time taken to "analyze" the biomarker data, as I understand from the call (and perhaps, waiting for OLE data). Which means two disappointing things:

1. Primary/secondary end-point data is indeed not pivotal/FDA-approval worthy, even in CM's eyes. Fair enough.
2. Analyzing biomarker data -- takes them 2 years (!) post-completion. That is certainly not reasonable, by any stretch of imagination.

Too bad.