Replies to post #350401 on Anavex Life Sciences Corp (AVXL)

[sab63090]

Thanks XenaLives,

The most important part was the Q&A....those 3 with Charlie Duncan, Spumit Roy, and Tom Bishop answered many open questions and basically made Adam F look pretty bad on his tweet.

He apparently did not listen or read the transcript....

[jimmy_mcyoloswag]

I believe our mystery analyst was Yun Zhong from BTIG:

https://research.btig.com/analysts/yun-zhong-phd/

[Bourbon_on_my_cornflakes]

TRANSLATIONS: Reading between the lines of the CC

Duncan: Regarding the expanded access, is that part of an open-label extension study or open-label extension to the AVATAR study?

TGD: So get me first on the last question. The idea is expanded access is to provide not only for those patients, which have been participating in the trials to give the drug for free so they can continue to enjoy the treatment effect, but also those patients, which are not part of the trial. So that is the definition of the expanded access. So that's what we are considering and working towards.

Translation: AVXL is now moving to actual sales outside of the trial participants in Oz.

TGD: in regards to the ClinicalTrials.gov, I would like to make, again, a statement here that the ClinicalTrials.gov is not what we want to refer as to company communication.

Translation: Lesson learned. We have to make sure we announce changes in a timely manner so AF won't distort it.

TGD: It's really in this paper from 2020, which came around the time when we finished our first study in the US study. And that's what we learned from that to adjust to this. And then the guidelines of the FDA guidance are really specific what to do in those cases. So we made it for the FDA easier. That's why I think the guidance is very clear.

Translation: We did what the FDA wants, so approval should be speeded up.