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plexrec

11/07/22 12:52 PM

#382001 RE: sokol #381999

sokol--" may to some degree result in drug approval."--good find- thanks--on our way !!!!!

Investor2014

11/07/22 1:08 PM

#382002 RE: sokol #381999

14% chance of approval for A2-73 in Rett seems reasonable.

abew4me

11/07/22 2:48 PM

#382019 RE: sokol #381999

Excellent post. Thanks for sharing your DD.

tredenwater2

11/07/22 2:55 PM

#382020 RE: sokol #381999

Sokol this is the first ODD we have received since Gottlieb was FDA commissioner and I remember distinctly Gottlieb saying that there was “backlog of ODD applications they were focusing on clearing up” (paraphrased). That being said I wonder if this is any indication of ODD for our mystery rare disease and or a few others come to light in the next month or so.

Still no bad news out of Anavex, only a long string of good news!

Doc328

11/07/22 3:18 PM

#382021 RE: sokol #381999

Here are links to the searchable database of drugs receiving orphan designation.


Click for the FDA's OOPD link. Type "Fragile X" or "Rett Syndrome" into the orphan designation box for the list.
28 drugs (now with A273, 29) have ODD for Fragile X and 14 for Rett. Might explain the blunted response to designation.
FYI, (2,2-diphenyl-tetrahydro-furan-3-yl-methyl)-dimethylamine hydrochloride is the chemical name for A273.

Click for EU link -- search under "B" for blarcamesine