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BIOChecker4

05/27/26 11:29 AM

#518839 RE: Boopka #518837

In Anavex’s trials for early-stage Alzheimer's, the data suggest that defining a population by specific genetic biomarkers (ABCLEAR 2 and ABCLEAR 3) yielded stronger responses to the treatment than looking at the general trial population.The data indicated that these specific subgroups on Blarcamesine showed a statistically significant reduction in cognitive decline over 48 weeks.

First, the data were generated from early stage patients (still to this day extremely difficult to diagnose) with specific genetic biomarkers that about half of patients have. That represents a fraction of the total AD population.

Second, there was a statistically significant reduction in cognitive decline over a period of less than a year. (We have no data beyond 48 weeks, so what happens beyond that is an open question.) A slowing of progression is a plus but hardly anything close to a reversal of the disease or a cure.

Third, there is no data to suggest that more advanced patients will see any benefit whatsoever.

My conclusion is that based on the data generated to date, Blarcamesine is mildly effective in a relatively small subgroup of patients. Is that enough for regulators? Maybe. Is that enough to justify a high-risk, multi-year investment? Maybe for some retail investors but I still don’t see biotech institutional investors taking that risk, especially when there are newer technologies that are showing greater promise.

Again, IMO, Anavex’s best asset is the cash on hand. Blarcamesine has limited efficacy in a relatively small subset of patients and there are newer and more promising technologies in development.
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Investor2014

05/27/26 11:39 AM

#518841 RE: Boopka #518837

With what we now know, or rather what we still do not know, about Anavex and its clinical trial data in general, I am not sure the risk has been reduced compared with the period before the Phase 2a open-label AD trial.

What we do know, cabal or no cabal, is that the CHMP rejected the results as presented by Anavex.

Adding an in-trial generated hypothesis, such as ABCLEAR 2 and 3, does not equal risk reduction.

What I am sure of is that this statement will get Hosai busy with ChatGPT trying to prove me wrong.