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falconer66a

04/05/24 4:36 PM

#455933 RE: plexrec #455924

If Australia, Then the World Right Away

I say go for approval in Aussie---makes the most sense---will be accepted by other countries !!!!!


Actually, approval of blarcamesine for Alzheimer’s anywhere in the world will lead to global availability.

If Anavex gets Alzheimer’s approval of blarcamesine in Aussieland, patients there will start to improve. Their therapeutic successes won’t be a secret. The drug will be safe (no side effects of any consequence), will be easily taken (an oral pill or two each day; no infusions at a medical facility), and favorable therapeutic responses will be quickly noted; including enhanced health-giving sleep patterns.

With reports of all of that in Australia — or anywhere else — there will be strong popular, even political pressures to make the drug available in countries across the globe.

XenaLives

04/05/24 4:40 PM

#455935 RE: plexrec #455924

OK - correct me if I'm wrong...

The Aussies have data on Parkinson's and Alzheimer's.

There is Rett Syndrome data from the U.S. and Australia, but they are applying for EMA approval based on unique criteria in that jurisdiction..

https://www.nasdaq.com/articles/anavex-avxl-up-12-on-regulatory-update-for-alzheimers-drug

PLEASE DON'T DISS this post. Correct and add DD, but all purely negative criticism will be ignored.

I am looking to build a correct and succinct statement of Blarcamesine' s position in the regulatory matrix.

BAR123

04/05/24 5:22 PM

#455943 RE: plexrec #455924

They are going for the FDA approval based on the fact that the FDA will be changing the rules for submitting an NDA. Why would you want to waste your time, money and resources on Australia when you have much larger fish to fry. Go EMA and go FDA.