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boi568

08/15/20 3:54 PM

#265439 RE: falconer66a #265438

I was just adding a thought.
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Boopka

08/15/20 4:00 PM

#265440 RE: falconer66a #265438

falconer, now let me throw you a curveball. We are in an election year plus we are talking about a drug potentially saving a country perhaps billions of dollars on health care costs. Coupled with that a well respected government agency friendly with the US, the TGA, that could share data going back 5-6 years now demonstrating both safety and efficacy for a high unmet disease featuring a low SOC. Is our FDA going to be so pompous as to not have high level discussions about 2-73? Will that at least get us to a fast track status or such?
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rayovacAAA

08/15/20 4:03 PM

#265442 RE: falconer66a #265438

WHY WOULD THE FDA SAY NO TO A DRUG THAT RECEIVED APPROVAL FROM THE TGA TO ADMINISTER TO EVERY AD PATIENT IN AUSTRALIA?????????????????


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.




WILL THE FDA NOT ACCEPT UNSUBSTANTIATED PHONE CONVERSATIONS AND EMAILS FROM IR AND THE TGA AS PROOF OF A2-73'S SAFETY AND EFFICACY???????????????