Replies to post #322845 on Anavex Life Sciences Corp (AVXL)

[RedShoulder]

I don’t think we’ve seen all the fallout from ADU’s approval. We may get new legislation around FDA approvals. Who knows. Thus my hedge that AVXL will require another P3 before approval.
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OTOH, FDA approval of a AD drug that actually works by improving cognition would help get them out of the firing line that have put themselves in by approving Biobleed a dangerous drug that hardly helps cognition.

Also I don't think we can imagine the tremendous pressure from AD groups, politicians concerned about Medicare cost, patients, and care givers for FDA and TGA to approve A2-73 Blarcamesine when the results show significant cognitive improvements.

The Ph-2 trial showed some AD patients improved and some did not decline, unheard of for an AD drug. I think the Ph-2b/3 trial will show similar results, possibly even better results. That IMO will result in FDA and TGA approval of the Ph-2b/3, followed by a Ph-4 while the drug is in sales WW.

[bas2020]

Thus my hedge that AVXL will require another P3 before approval.

Thankfully, 2-73 will be granted TGA PA well before that unlikely possibility... as it will put pressure on the FDA.

[Rubyred77]

I’ll bet against your hedge.

If A-273 is already approved for Rett and possibly PDD with no serious side effects among all trials…,.

Didn’t Missling attend a conference about basket trials/master protocols?

A Basket Trial involves a single investigational drug or drug combination that is studied across multiple
cancer populations defined by disease stage, histology, number of prior therapies, genetic or other
biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating
trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study
may allow for expansion to generate data that could potentially support a marketing approval.

https://www.fda.gov/media/125556/download