The brain shrinkage issue is not hairy. It's whole brain shrinkage, a known measurement for AD. We can be quite confident in the basic result -- the p value is .0005 and the effect being examined is physical rather than behavioral, so it's not like we have any measurement issues. And to my knowledge a reduction in whole brain shrinkage, at any level, is unprecedented for AD.
I was able to make a reasonable calculation of the undisclosed relative improvement (~20%), but the FDA will have the underlying numbers and won't have to guess.
I also think the brain shrinkage reduction rate will improve over longer dosing periods. Effectively, blarcamesine is being used prophylactically for neurons that have not deteriorated, and the proportion of those healthy neurons in a patient with MCI or mild AD will only increase as the diseased neurons die off. (Clearly, during an initial dosing period there will have been neurons that were too far gone to be saved, and some that will be salvageable.)
When you look to predict FDA behavior, recent past performance is key. They have been approving riskier drugs with less efficacy, albeit a greater certainty regarding those efficacy levels. Will a greater certainty in poor efficacy, with real risk, count for more with the FDA than safety, good efficacy, and a reduction in pathological brain shrinkage? Just what is the true downside to the FDA in approving blarcamesine in that context?
I think as we see more AD results trickle out from Anavex, the arguments here -- from the good faith posters, I mean, not the ones I've blocked -- are implicitly centering on our expectations of the FDA more than anything else. I think there's a consensus that Anavex will give the FDA enough data to allow it to exercise its approval discretion, pro or con. On the other hand, I think the implicit argument that Anavex needs to produce enough data to entirely remove the FDA's discretion in order to get an approval is a mild form of gaslighting.
We're all longs here, or at least we all claim to be, so we've placed our bets. I have recently increased mine.
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