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Re: plexrec post# 454816

Saturday, 03/23/2024 2:19:32 PM

Saturday, March 23, 2024 2:19:32 PM

Post# of 460020
Plex....would believe that Anavex is preparing the Alzheimer's data with both the EMA and FDA requirements as as objective goals. One of the reasons for the EMA at the head of the sequence of submittal is probably the plan for achieving the monetary benefit of accelerated approval with Rett. Whether that will come is now questionable. The peer review is of course out of Anavex's hands, but will be beneficial to both submissions. One will build on the other and there will be a an accelerative factor in dealing with both Agencies. With the Rett OLE data, I believe that submission will proceed with Rett families encouragement.

When you review all the trial and submission activity with Alzheimer's, Rett, Parkinson's, Schizophrenia, Fragile X, the medical and financial world is wondering how such a small biotech is able to handle it all. Someone will have to find another equivalent size biotech with the same scope. Drug development is extremely hard and laborious....maybe some of the naysayers on the board could come up with numerous examples of similar sized biotechs with the same scope of drug development and facing the same level of challenges!
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