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Monday, 11/16/2020 1:59:04 AM

Monday, November 16, 2020 1:59:04 AM

Post# of 459058
RETT! Fastest Approval EVER!!

On the Rettsyndrome.org call 2nd question. "IS THERE AN NDA FOR Anavex" This is why Rett Syndrome is hot ?? listed and an FDA priority. There are no approved drugs and parents of Rett children are pounding the FDA to speed up the process!! IR was saying on good results in this 001 Rett trial results, if good, we file this year! As soon as parents see an FDA filing (parents are watching ??)has occurred that will set a storm of calls and letters to the FDA for immediate approval!! Normally under Accelerated approval I expect an FDA review date by July if filed in December, but Accelerated approval allows the review date to be early!! Opdivo had Accelerated approval with a June PDUFA date and got approved in April. I could see this as a record speed approval like late May!! This has nothing to do with stockholders! On amazing results the FDA will be under tremendous pressure from parents with Rett Syndrome to get the 1st ever Rett drug approved for sale! Anavex will need to produce enough for thousands of patients very quickly!! Just bring on amazing results!!
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