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boi568

11/01/23 3:01 PM

#437796 RE: scorman1 #437793

I am not making my statement based on a link. I am comfortable using my decades of experience of working in the Headquarters of a federal regulatory agency as background for that statement.

But as to your remark about biomarkers -- a novel MOA may well present novel biomarkers, something that would require a convincing scientific showing to the FDA, something that would take additional time, and something, in the context of a potential platform drug, worth investing in now for payoffs down the line.

Nothing this ambitious fits within your paint-by-numbers approach, since an entirely new picture is being painted. You really have misread Missling if you think he is an unimaginative incrementalist.
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Steady_T

11/02/23 12:11 AM

#437829 RE: scorman1 #437793

I am reminded of a comment by Carl Sagan " Extraordinary claims require extraordinary evidence".
Anavex is challenging the entire Alzheimer's disease paradigm.

So yes, the FDA will be looking much more carefully at Anavex's data and trials before granting approval.