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rayovacAAA

03/31/21 1:04 PM

#305348 RE: RedShoulder #305343

WHAT REGULATORY AGENCY IS SAS?????????

I'm highly optimistic that FDA and SAS will approve A2-73 Blarcamesine for PDD on this data alone.



WHAT DRUG APPROVAL AUTHORITY DOES "SAS" HAVE????????



GOOD LUCK AND GOD BLESS!!!!!!!!
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rayovacAAA

03/31/21 1:45 PM

#305360 RE: RedShoulder #305343

WHAT REGULATORY AGENCY IS TGA/SAS?????????

I'm highly optimistic that FDA and TGA/SAS will approve A2-73 Blarcamesine for PDD on this data alone.




WHAT DRUG APPROVAL AUTHORITY DOES "SAS" HAVE????????



GOOD LUCK AND GOD BLESS!!!!!!!!
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Jonjones325

03/31/21 1:59 PM

#305361 RE: RedShoulder #305343

I agree. These results are hard to ignore and were so good that we got a late breaking at the CTAD.

The full data will be eye opening with actigrapghy, sleep measures and other secondary endpoints.

Depending on the strength of these, and there is no reason to believe they aren't strong, IMO the FDA and/or TGA will grant us some type of accelerated pathway.

Also agree that we will not here more until either the peer review is complete or a regulatory body has rendered a decision on whatever.

Whether it be a phase 3, AA, PA, BTD etc. They are all wins of varying degrees.
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intuitive3

03/31/21 2:33 PM

#305373 RE: RedShoulder #305343

Red, is Michael J. Fox and his foundation on board actively supportive in addition to granting money?