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Re: tredenwater2 post# 458960

Tuesday, 05/14/2024 2:52:27 AM

Tuesday, May 14, 2024 2:52:27 AM

Post# of 460137
Missling has said he wants the OLE data before filing with the FDA.

Somehow I doubt that the FDA is that concerned with the EMA. Given what Missling said about starting with the EMA first because their process is the longest, he may be planning for the FDA and the EMA to have decisions in about the same time frame.

The EMA has a greater sensitivity to the costs of a drug and the costs to the economy than does the FDA. I suggest that is why the EMA was "pulling" on Anavex. The FDA doesn't weigh those considerations as we have seen with the mab approvals.

I may be naive in my thinking on this. Certainly the FDA and all other agencies would like to see a successful AD drug that is easy to administer and comparatively cheap make it to the marketplace. That would be a political win, a bureaucratic win, and a medical win.

Nunc est Bibendum

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