Replies to post #316357 on Anavex Life Sciences Corp (AVXL)

[RedShoulder]

This does raise one question for me, will the FDA wait for the pediatric trial results before considering 2-73 and approve it for all Rett ages or will the FDA approve 2-73 in adults first and then consider pediatric usage.

Steady, that is THE question going forward.

[Investor2014]

I agree.

Although for accelerated approval a surrogate endpoint biomarker is required, meaning that it implies efficacy. Levels of amyloid plaque afaik has never been shown to be or accepted as a surrogate indication for level of dementia.

So yea why not SIGMAR1 variant vs WT. scores.

[boi568]

I also agree that today's PR sets down a marker for AA for Rett. We look very good here on that criterion.

[Jonjones325]

What’s the point of waiting? So the adult patients can get worse in order to save some paperwork?

Seems illogical. Then again so do a lot of things the fda does.

[tredenwater2]

This does raise one question for me, will the FDA wait for the pediatric trial results before considering 2-73 and approve it for all Rett ages or will the FDA approve 2-73 in adults first and then consider pediatric usage.

Should have raised two questions, will the Fda give accelerated approval for Parkinsons with the episodic memory improvement and perhaps biomarkers we are seeing across multiple diseases now? Basically each trial is confirming and building on our Ph 2 a as these arent completely brand new hypothesis we are driving here.

Build the case Dr Missling and then peak early at Alzheimers right before you announce the mother of all partnerships for Alzheimer’s!