Anavex Life Sciences Corp (AVXL)

[abew4me]

Show me a drug that the FDA has approved...and the EMA has rejected? That's easy....Biogen's Alzheimer's drug called Aduhelm

And I'll bet Australia's TGA also rejects the FDA approved drug from Biogen.
https://www.smh.com.au/national/new-alzheimer-s-drug-unlikely-to-be-approved-in-australia-soon-say-experts-20210609-p57zlc.html

You see, things change.

So don't be surprised if the TGA approves Anavex's drug even if the FDA delays their decision. Here's why I believe this:

Approximately 50% of the patients enrolled in the P2b/3 AD trial came from Australia...and therefore, their overwhelming representation should allow the TGA to take the lead in the decision-making process.

Heck, I wouldn't be surprised if the TGA makes their decision before the FDA even makes a comment.

This is just my opinion, of course. But I believe the FDA has lost their role as the Gold Standard around the world.

Cheers.