InvestorsHub Logo
icon url

go avxl

01/02/24 1:51 PM

#445352 RE: rx7171 #445347

good question


Why TBSD can't even get an NDA for it
icon url

ImGettingBetter

01/02/24 2:06 PM

#445365 RE: rx7171 #445347

I thought the issue for avatar was the small sample size. So, Excellence was going to bring it all home for potential approval. I guess we will now have to wait for Anavex to get with the FDA and determine next step as noted in the PR this morning. What a tough day....
icon url

frrol

01/02/24 2:46 PM

#445385 RE: rx7171 #445347

Avatar apparently had similar data to Excellence. But since Avatar was reported as AUC and without graphs, many here don't understand this; they think Avatar was "the successful one". But there's a reason Avatar proved not to be pivotal either, and it wasn't fantastical TGD strategery timing for a Rare Disease Voucher; it was poor final (week 7) results vs placebo. We now have a much larger (3x) pediatric trial, and it has poor final (week 12) results vs placebo.

The company sounds like they will ask regulators if they should file a Rett NDA. No harm asking. But the Excellence results will likely be received as the Avatar results were, with a head shake. In the meantime, about time we finally get FX, PD, and Schizophrenia started, get that AD paper done, and get some AD OLE results. And hear about some more AD filings underway.