Replies to post #350597 on Anavex Life Sciences Corp (AVXL)

[Pipilongstocking]

Agree.

[Investor2014]

Avatar results will receive the go ahead nod from FDA

For Expanded Access yes, likely not approval until after Excellence. so no cruelty in the US with Expanded Access, nor elsewhere should various other country regulators allow similar compassionate access.

[abew4me]

Agreed. That's why I wrote this other post (responding to e2w) last week.

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e2w...thanks for your feedback.

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Your quote: "It is one thing to be safe on someone older with AD versus someone younger with Rett Syndrome, and for kids it is even more unknown."

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Let's dissect your quote and make sure we're comparing apples with apples.

First of all, we're not talking about approving A2-73 for kids...so let's take that out of the picture altogether.

It is for Rett adults 18 and older...and "the average age of death for patients with Rett syndrome is about 24 years and in most cases, death is sudden and often secondary to pneumonia." https://www.emedicinehealth.com/what_is_the_life_expectancy_rett_syndrome/article_em.htm

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Your other quote: "I think the weakest link is the limited data for only 7 weeks on a chronic condition that does not have urgency as part of the problem."

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Try telling that to the parents/caretakers of an adult with Rett syndrome. If the average age of death is 24 years old, then I would argue that time [urgency] is of the essence. (True, some live into their 40's and maybe a few can make it to their 50's with a lot of care...but those are the exceptional ones.)

Do you really think the FDA is going to dismiss the 7-year safety record just because it was based on elderly patients with AD?

And FWIW, Anavex does have a safety profile for Rett adults that goes back to 2019 from the original six adults that participated in the first Phase 2 trial. (See below)

"Preliminary Clinical Data is derived from the ANAVEX®2-73-RS-001 study on the first 6-patient cohort ranging in age from 18 to 36 years, who completed the pharmacokinetic (PK) part of the study and who received a low dose of approx. 5 mg daily oral liquid dose of ANAVEX®2-73 (blarcamesine) for 7 weeks. Patients are continuing participation in the ANAVEX®2-73-RS-001 open label extension study."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167772514

[end2war]

A small delay to allow vaccinations is not a big deal, IMO. It does not change anything material.