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Re: None

Friday, 04/29/2022 11:25:35 AM

Friday, April 29, 2022 11:25:35 AM

Post# of 463862
Ok how about this for a theory. We all know that we are awaiting on the company to submit their Rett P3 data to the fda and look for guidance. We also know that we are awaiting some movement from the company or the fda for next steps as it relates to Parkinson's Dementia. And finally we are waiting on the company to finish the Alzheimer's P3 trial and release data.

So the theory is the company is not looking at submitting each individually but will be submitting the entire package as a whole in the August timeframe looking for approval for all indications based on the TOTALITY of the DATA. If they don't get approval for all, the other scenario could be the FDA approves Rett for Accelerated Approval for adults, submit the pediatric when they trial is complete for that approval. Tells the company to run a P3 for Parkinson's Dementia / Parkinson's. And the big winner, Approval on Alzheimer's with the caveat to run a P4 for Alzheimer's just like they did with Biogen. Major victories all around.

Even worst worst case, the have to run another P3 for Rett, run a P3 for Parkinson's and run another P3 for Alz. You may think that this option could be a kiss of death for the next year but.........it puts a firm timeframe on each of the indications. Another Rett trial would be 6-9 month with a firm timeframe for approval. The stock can go up. Same with Parkinson's and Alz. We will now have a firm target on our back for success or failure and with the FDA setting the timelines only one way to go is up. Your thoughts please.
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