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Thursday, April 12, 2018 12:54:04 PM
Neuren's Deal With FDA Reduces Uncertainty -- Market Talk
During my discussion w/Clint(Anavex) this AM we discussed the investors benefits from trials. I told him my story on how I believe risk varies as a function of uncertainty. As information flows with knowledge then risk is reduced as uncertainty is mitigated. As the trials process starts then dates/facts and information begin to flow. Calendars, spread sheets and schedules can be set and BINGO risk is reduced in the process. We all know what happens when risk is reduced...sp should increase even w/o news flowing. And so it goes. He assured me he thought the RETT trial will be part of Dr.M. comments with the ASM meeting, possibly sooner and we should confidently expect the RETT trial to begin in Q2. He also still expects all 3 trials to begin CY2018.
He said the MA w/BIIB is till alive and moving but MS is at a very early(petri dish) stage. Not even close to precision medicine trial level discussion. The Lund PD trial is on schedule and expects it to start along w/AD in CY 18.
Take aways from conversation with Clint:
a. Very positive working relations w/FDA on new precision trial/planning.
b. FDA being helpful, working closely w/AVXL team on RETT PM protocol.
c. MA w/BIIB still alive and working but at first stages.
d. Significant information/knowledge from AUS AD trial will be used to plan/select pts for next trial. Quite important on who will/will not be in AD trial based on (assume markers) knowledge.
e. AUS AD trial still active, pts expected to extend further as time goes on, some pts actually able to do things (no details) they were NOT able to do b/f trial started. ( I would be VERY cautious w/this but he was clear about reported improvements continuing).
f. He suggests that other investment agents will get on board as trials progress, this is a normal results risk mitigation outcome as he sees it which normally occurs when trials/results/more information starts to flow and more people get information on what we are doing.
h. Policy of silence is based on limited resources and avoiding phony legal actions.
I. FDA is informed on AD results/new marker information from AUS. trials which will be applied to new U.S. trials.
K. Expects relevant updates from/prior to meeting Tuesday.
Note: I am trying to accurately and honestly convey what Clint said in response to my questions. I am not hyping or spinning anything nor will I overstate his position. He did agree that the thesis on CNS Homeostasis makes sense.
I got the sense AVXL does understand the stress/anxiety associated with silence policy. We had a frank discussion on this point.
Recent AVXL News
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- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
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