Anavex Life Sciences Corp (AVXL)

[Talon38]

Falconer, the Alzheimer's Clinical Trial Consortium(ACTC) is an indication that the FDA/NIH/NIA is not conducting business as usual. Board members should read the NIH press release again. It outlines that the ACTC will be NIA funded by up to $70M over the necxt five years to provide trial infrastructure and other support (see listed) to combat Alzheimwe's. Additionally ..."Funding opportunity announcements for specific ACTC trials are expected to be released in early 2018 and will be open to all qualified investigators.".

This is the Center of Excellence (COE} for Alzheimer's that Scott Gottlieb has indicated he wanted to field to join the FDA's COE for Cancer. In my estimation, this is what is responsible for setting the structure and timing for our AD P2/3 and additionally our negotiations for our AUS P3.

As to the Rett Syndrome trial....since we are dealing with such a young and fragile patient population, IMHO Dr Kaminsky and the ANAVEX trial experts are making doubly sure sure of the safety and feedback aspects of the trial. We also must take into account that Kaminsky also has to share his time monitoring the Neuren drug P3 start....so he has his hands full.

The PD trial is anyones guess but, it is complex because of having to coordinate and clear all aspects of the trial with the FDA, MTA, the trial host (Lund?) and the European arm of the MJFF. Complicating this process is the fact that the MTA will be moving its HQ from London to Brussels in 2018. Consequently. the PD trial may be the slowest of the three to develop.

Still think we will see 2-73's MS application move to human trials in 2018. My guess is that Biogen or WSU will be leading that charge

When there is such a wide application for just one drug, we (and the FDA) have to be intrigued.

-------

https://www.nia.nih.gov/news/new-nih-consortium-award-enhance-clinical-trials-alzheimers-disease-related-dementias