Dec. 4 at 9:18 PM
$CGTX Hey Lisa! I think a letter to the FDA Commissioner is in order! "We would love to help you with that, and we can!" There's some FDA-imposed technical reasons why zervimesine can't be considered for accelerated approval (I've learned), but it seems that the FDA could redefine what qualifies as an accepted biomarker for AA. It's not like the one biomarker they use (only amyloid plaque reduction) has produced any fantastic drugs for AD, or any for DLB. And on the DLB front, in light of these comments, the FDA should reconsider its verdict on the BTD decision for DLB, if not grant AA for it. The FDA seems stuck in the past when it comes to AD science, AB oligomers and Tau very likely play a huge role in what is driving the disease to get progressively worse, yet progress for approving, funding, and testing drugs that target those aspects are insanely slow. On the funding side... probably because of the FDA's stance! Seems like they need to revise their stances, given newer science.
