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kld2

06/06/17 3:10 PM

#107384 RE: XenaLives #107382

what would the odds of 19 people on the same drug getting better



Wish we knew. All we need is a Ph2/3 trial with a large number of patients to find out. Thanks for asking the question.

nidan7500

06/06/17 5:24 PM

#107397 RE: XenaLives #107382

Dr. M has a thesis which would be more correctly stated by himself. My version is he claims cell homeostasis in CNS appears to impact a number of previously incurable CNS diseases, such as Rett, AD, autistic spectrum, Parkinson's and more. Evidence supporting his claims include AD human trials and animal preclinical trials for other indications. No failures have been reported to date to disprove this Homeostasis stability theory.

There is no record that we know of on any human ever maintaining cognitive skills much less recovering as some claim to have with A2-73. Some stories have been largely dismissed as anecdotal, possibly false claims. So, we debate. I claim that unless these claims are lies and the data to date is false the thesis is proven true. Who knows what level of exhaustive testing the medical/regulatory universe needs. In the meantime we are caught in some unprovable hell where only a saint could be calm.

So, unless and until some contradictory evidence is shown I believe the claim is proven and suggest the FDA or other such body must step up and lead. Then we all get on with life. The FDA must work to define a test process which will put this to rest. Since no human has ever recovered it seems obvious the risk is low. Massive, exhaustive, expensive testing seems a waste since the thesis can easily be proven by logic. A2-73 presents no risk considering the alternatives. If it were my little girl I would at least try instead of bowing to BP. It is clearly the FDA's call.

Definition:
plural noun: theses
1. a statement or theory that is put forward as a premise to be maintained or proved.

synonyms:
theory, contention, argument, line of argument, proposal, proposition, idea, claim, premise, assumption, hypothesis, postulation, supposition

TomP1

06/07/17 3:47 AM

#107443 RE: XenaLives #107382

The odds are there.

Know of any other drugs that got approved based on n=19?
I don't and neither does Anavex.

Thats why they plan an n=300 p2/3.
Thats why Missling said that perhaps even more trials could be required