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chrismiss_everyday

11/21/23 7:31 AM

#439570 RE: boi568 #439563

What about the stateside Rett timeline?

Steady_T

11/21/23 7:42 AM

#439577 RE: boi568 #439563

The EU process makes the FDA process look swift.

Kmadd

11/21/23 8:00 AM

#439583 RE: boi568 #439563

In my same type of research I noticed the EMA gave Anavex an orphan drug designation, I believe for Rett, and was wondering if that could at all play into the timeline? I would think if data and submission timings of Rett are favorable, it may influence the speed at which AD could get through the system.

nidan7500

11/21/23 8:44 AM

#439593 RE: boi568 #439563

boi568

EMA Timeline I've been digging into the EU regulatory process to figure out our timeline. It's going to take a while.

..agree w/process facts and thanks for the summary outline of schedules....BUT, IMO, after decades of CNS diseases deaths and pain at some point (under certain conditions to be determined)...Humans will push the process for expeditious-urgent -emotional relief. ENOUGH IS ENOUGH. As results begin to flow and a pattern of low/no adverse effects percolate up from well controlled and informed sources then strong human reasoning will prevail.

Someday soon, the AVXL CAT WILL BE OUT OF THE BAG and (after decades of outright failure) no half-axx regulator will be able to stand in the way of humanitarian urgency to act. I am a "play by the rules guy". BUT...."THE CAT IS (or will be) OUT OF THE BAG". Don't screw this up.

Jonjones325

11/21/23 10:00 AM

#439609 RE: boi568 #439563

Hope TGA is the next shoe to drop. Quickest path?