Replies to post #358940 on Anavex Life Sciences Corp (AVXL)

[frrol]

The company has disclosed that intention. Rett is an orphan rare disease, so it is a prime candidate for BTD's. It's disappointing we haven't applied or been granted it (by this time it would have been, it's a relatively simple application, not part of a full clinical report), so the FDA is likely wanting Excellence results; the adult trials showed potential signal, but no apparent dose effect in Avatar. So let's see what Excellence shows. I'll be surprised if TLR comes in by end of H2 2022. It's looking like it's going to be another target date pushback, maybe to Q1 2023.

[rayovacAAA]

PURE FANTASY!!!!!!!!!

There is zero risk to the company with EXCELLENCE already in flight and reading out by year-end.

THE A2-73 EXCELLENCE RETT P2/3 TRIAL EXPECTED COMPLETION DATE ISN'T EVEN UNTIL DECEMBER OF 2022!!!!!!!!


https://clinicaltrials.gov/ct2/show/NCT04304482?term=ANAVEX&draw=2&rank=4

[raja48185]

They will file for adult rett approval. There is zero risk to the company with EXCELLENCE already in flight and reading out by year-end. The worst case, short-term scenario is a CRL indicating they need more data or population, which they have in flight and pre-negotiated with agency via EXCELLENCE and its now 85 patients, ages from 5-17 years old…this data set building on the prior US Rett and AVATAR studies. I fully expect they go for it since they lose almost nothing in trying

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Yeah, we will see. Not sure about year-end read out of EXCELLENCE trial.

Should they get a CRL from the FDA you might see the stock price tank another 25% to 50% - that is your nothing, zero risk. But yeah company loses nothing but for a set back in MC