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powerwalker

06/07/17 7:47 PM

#107571 RE: tredenwater2 #107569

Tred, your point is well made.

If the 18 month data presents a picture that each participant in the Aussie trial (n=25) has shown stabilization (no further decline) or improvement, then there is no reason for any further reluctance by any national FDA-type organization to withhold 2-73 from its citizens. The governments might want to continue an evaluation of the results, but given its safety, 2-73 should be made available IMMEDIATELY!

As any statistician would recognize: if results from all previous trials are 0 in xxx,xxx to one that shows 25 for 25, it is significantly important!

P.S. Even if it is 20 of 25, the conclusion is the same.

nidan7500

06/08/17 7:45 AM

#107608 RE: tredenwater2 #107569

OK...Harvard promotes a method in selected programs called "Breakthrough Thinking". A definition posted below, I believe it is relevant in AVXL-FDA trials context. If Homeostasis is what Dr M says then all bets off. I also think the FDA will act accordingly.

"Deliberate, focused effort aimed at developing radically new approaches that overcome constraints, instead of making incremental changes in the older ways of working"