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jimmy667

03/03/18 11:03 PM

#143272 RE: sokol #143271

If there is a significant mediation of seizures in RETT then one would think the NIH would quickly fund trials in other indications that exhibit seizures as well as Epilepsy itself.
Long Anavex Life Sciences.

nidan7500

03/04/18 8:36 AM

#143283 RE: sokol #143271

[quoteAnavex has been collaborating with the Rett Foundation and the FDA][/quote]

This kind of printed message is clear evidence of a collaborative effort by FDA/RETT and AVXL (probably others also) and is consistent with how the FDA has managed regulatory changes in the past. (see GHT as example).

As a regulatory body the FDA is required to write rules/guidance and organize the process. This can be hard to do on the run but the conference PR shown by Talon is showing how the sausage has been worked on. They could not use this kind of precision in PR w/o a lot of work already done. Also, some of us have seen A2-73 RETT trials as the Precision Medicine choice and poster child rollout by speculation and now it looks like that was possibly a good call. Hard not to get out in front of ourselves on this.