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Re: Kentucky123 post# 353657

Wednesday, 03/09/2022 6:10:08 PM

Wednesday, March 09, 2022 6:10:08 PM

Post# of 471562
Have nothing to contribute. Clinical data will prevail.

Falconer of all the people on this board I would think that you would take the opportunity to ask a question or comment to the FDA regarding A273.

Thank you.

But I’ll respectfully decline. FDA doesn’t know (or care about) me at all. My questions or suggestions would be copied and pasted into some big document, “for further consideration,” I fear.

Regardless, two most important sets of data will determine the FDA’s action on blarcamesine as a Rett therapy: a) most importantly, the clinical outcomes data, and b) the voicings of both Rett patient parents and the medical people attending them.

It appears that the clinical outcomes data, alone, should prompt FDA approval. But with numerous, heartfelt queries from Rett parents, care givers, and medical professionals, action should be accelerated. I encourage their useful participation. If Aduhelm could gain FDA endorsement, based upon really weak clinical outcomes, blarcamesine to treat Rett should be a walk-in. I wish I had information I could contribute to facilitate this. I don’t. Like most others, I’ll stand back and observe.
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