Replies to post #265429 on Anavex Life Sciences Corp (AVXL)

[falconer66a]

No, just in Australia.

I doubt that this thoroughly back door route to Australian approval would move the FDA to approve 2-73 for AD without a blinded, placebo-controlled trial.

Sorry, didn't mean to imply (don't think I did) that TGA approval of blarcamesine, after the new SAS "approval" would prompt the FDA in the US to approve blarcamesine. The FDA will wait for more complete, comprehensive clinical trials results.

But, can Anavex Life Sciences Corp become a commercially more viable firm with approval of blarcamesine for Alzheimer's way down in Australia? Presently, blarcamesine is unapproved for treatment of any disease throughout the world. It's a drug merely in clinical trials. For CNS drugs, a great percentage of these never survive clinical trials. The trials reveal either inefficacies or safety concerns; the drugs get discarded. Who would consider investing hard-earned funds in a start-up pharmaceutical company that, first, targets CNS diseases, but has none of its drugs approved for such use? Such is the case with Anavex Life Sciences Corp, or its AVXL shares.

Let's see how things change, should the Australian "FDA," their Therapeutic Goods Administration (TGA) grant full sales approval of blarcamesine "down under."

Sure, Australia has only a small population. There are reports of over 342,000 Alzheimer's cases in that country, compared to a report of 5,700,000 cases in the US. The number of cases in Australia is only about 6% of those in the US.

So, how would an announcement by the TGA (and Anavex) that blarcamesine could then be used to treat Australians with Alzheimer's be received? Would the Wall Street Journal, or the New York Times write an article on this?

Let's take the New York Times. Which would be the article title? "Questionable Drug for Alzheimer's Approved in Australia." Or, "Aussies Now Have New Hope For Alzheimer's."

More accurately, given the profound level of investment expertise for start-up pharmaceuticals on this message board, how would this development be rendered here? "Whoa! The TGA has made a big error; don't buy any AVXLs." Or, "Well, Anavex is now officially in the game; has a product to sell."