Replies to post #137221 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Well, MY, MY , MY...what have we got here...?

• Explore the development of a policy framework under which an accelerated approval approach could be used to support marketing of a drug that demonstrates a survival benefit early in clinical development. The goal is to expedite availability of a therapy while the magnitude of the benefit it provides is being confirmed

These rules suggest exactly the opposite of longer, bigger, more expensive, statistically blah, blah, blah sample size blah, blah blah, ...not in our lifetime blah, blah, blah, BTW...IMO, blah, blah modeled trials. Can ew say...Real World Evidence?

[polarbear77]

Game changer.

Logic on display this morning, thank you Nidan/Inv2014/Jimmy667.

Dr M and Dr Fadiran must’ve had good reason to believe that the upcoming new CNS guidances (alluded to by Dr G during 9/11/17 FDA speech) would include these types of adaptive/accelerated approval capabilities/RWE/reliable natural history placebo arms/shorter more efficient trial designs/using patient perspectives/precision medicine & AI for drugs targeting unmet medical needs.

Likely we were not able to obtain ph2/3 AD trial protocol approval from FDA until said new CNS disease guidances were announced/released.

Just announced by fda in January 2018.

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf

Full guidance documents soon to be released it would seem.

Stands to reason why Dr M said on 12/11/17:

“We are currently in the process of making the necessary regulatory submissions for the Phase 2/3 trial, which we expect will be completed within the upcoming quarter.”

And,

“We are looking forward to 2018 to applying all diligent proprietary work, including the integration of genome sequencing information from patients treated with ANAVEX 2-73, which we expect will enable more robust regulatory submissions.”

This fda/regulatory paradigm shift really could not have come at a better time for CNS targeting biotechs, such as ours.

GLTAL and go Anavex.