Replies to post #367030 on Anavex Life Sciences Corp (AVXL)

[Doc328]

The unfavorable Nuplazid news from 6/21/22 is still overpowering the SP for that company. sales for the PD psychosis indication have plateaued and they were hoping for AD psychosis. The Nuplazid Advisory board outcome, though not entirely unexpected, could still have gone the other way. The Rett NDA around this date was a given with the only question being June/July or Aug/Sept.

Approval for trofinetide in 2023Q1 will likely occur before TLD release for Anavex Excellence study unless the FDA pushes the date back. Though first to market is always nice, being second to market benefits from the raised awareness to family and doctors. Also, second to market can learn from positives and negatives of the first drug's launch

[falconer66a]

Yes, We Will See

As to the impact of an FDA approval for Trofinetide for Rett, I expect ACAD will move significantly higher because the stock will have been dramatically de-risked and because the approval of the first drug for a terrible childhood disease will generate global media interest and coverage. You can bet Rettsyndrome.org and other Rett advocacy groups will be pushing the story hard to healthcare reporters globally and so will Acadia. You’ll see.

Well, this is so important to know. No one else could have explained it so well. It’s all been bio-checked. Thanks.

When Trofinetide gets approved to treat Rett syndrome, it will become not only the SOC (standard of care) preferred drug for the disease (way out in front of any others), but few after that would even consider prescribing or having their daughter take blarcamesine, when it, too, later, gets approved for Rett.

Important things to understand about new drugs (apparently). First to market is not only the best drug, but the only one that would ever subsequently be used; no matter what else....

....such as frequent diarrhea as a side effect. Mothers with Rett syndrome girls will absolutely reject blarcamesine when it’s approved. “Nope, my girl isn’t going to take any of that new drug. Who cares if it has no side effects? First is always best. We are duty-bound to continue with Trofinetide. We’ve learned how to deal with Susie’s frequent diarrhea. It’s a mess, but who’d want to take a chance on some runner-up drug, which the FDA didn’t approve first? Yea, I know, the clinical results show that blarcamesine doesn’t cause diarrhea, and Anavex clinical results claim it has better symptomatic control than Trofinetide, but who could trust the clinical results from a company that couldn’t finish a trial quickly?”

Then, of course, is the revelation that there are but a limited number of dollars available in the equity market for companies selling drugs to treat Rett syndrome. Again, first to market wins. ACAD will get all of the dollars; none will be left over for anyone to take a position in AVXL. Similarly, no stock investor would ever sell her ACAD position and acquire AVXL shares. You only get to invest, once, in a biotech. Can’t sell and buy something else later; no matter how much better blarcamesine eventually proves to treat Rett.

ACAD has this all locked up; Anavex should just walk away from Rett. It will enter the game after it’s started. No chance whatsoever. First in always wins. Anvex; too late to the Rett game.