Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Thank you, polarbear, great info!
Agree completely with your insight about the wisdom of wait (weight broke the wagon...hogwash, ha.)

But, there’s more to add, if I may.
Long story short: the FDA has rethought and will redesign new guidances related to biosimilars following a recent Supreme Court ruling in favor of the biosimilars being able to compete more easily (less red tape and less stringent statistical data and batch analysis needed) as compared to biologic drugs.

While this involves Anavex tangentially (makes it a more promising buyout candidate), it helps explain why all of the BP MaB’s went away. They could not protect their IP and charge high prices this recouping their sunk expenses.

Now that the Supreme Court has ruled, the FDA announced it will take the matter under advisement and revise guidances.
FDA withdraws draft guidance related to biosimilar developmenthttp://www.seekingalpha.com/news/3367537

A2-73 is a small molecule compound so we are patent protected. No biosimilar problem here. No concerns, please.

However, Biogen is still testing their MaB (monoclonal antibody) drug for AD and following the SCOTUS ruling and the new FDA guidance...as well as Biogen’s penchant for buying/licensing compounds which are in late stage trials..,(and their stash of cash)...

Connect the dots as you see fit.
Always the insightful thinkers, you and the message board contributors.

Thanks, have a splendid Independence Day,
Bio
(Incidentally, I am a polar bear. Allegheny and Monongahela Rivers 34 degrees water, -7, yep negative 7 degrees F. Tremendous! Wish I could go in now - it’s in the 90’s here.)