Replies to post #121641 on Anavex Life Sciences Corp (AVXL)

[Amatuer17]

“So why would Anavex jump the gun and preempt the FDA's time frame on announcements etc under these new trial guidelines? Shouldn't Anavex navigate the political minefield so as to avoid any costly missteps? “

Where did Anavex or Dr M said or even indicated that he was delaying starting of trial due to new fda rules?

It was pure speculation by members here as a defense of Dr M not doing any progress on any front for 4-6 months. Then suddenly this new defense started and has no basis for it.

Let’s hope we get some explanation tomorrow - not necessarily direct from Dr M but from tea leaves from his words.

[CkFacts]

RETT TRIAL

Great summary polarbear !

Re Talon38 's post 121652 earlier today concerning Rett trial , please note that on Sept 8 an FDA workshop entitled " PEDIATRIC TRIAL DESIGN AND MODELING : MOVING INTO THE NEXT DECADE " was held in Washington , and info was posted on FDA website on 9/21 .

Not sure if this counts as official release of trial guidance, but the timing sure fits !

GLTAL !

[makemydaze]

Great questions Polar - putting a lot of our thoughts into words.

"Therefore isn't the most logical reason for the delay the FDA guidelines and trial protocols announcements/negotiations?

What else could it be?"

Tomorrow is a mystery - presentation at 330 - seems like no webcast for Anavex - we don't even know if Missling will be there for sure.

What would be worthy of all this silence? If it was an announcement about a Biogen licensing deal for MS would that make us back out of the big July Alzheimers conference? I don't think it would.

It really is just about a year (last Sept 28th or so) since the Biogen interest was announced - just saying---

https://insiderfinancial.com/anavex-life-sciences-corp-nasdaqavxl-and-biogen-inc-nasdaqbiib-a-perfect-match/

I'm trying not to get my hopes up but this has all been very strange.

[nidan7500]

Bear...above and beyond as usual. IMO, he is "in your face" confident and he is making a statement about how past trials have been done and what will follow from here. All we have to decide is, is this guy incompetent (no-one/few who has studied his work would suggest that) . He is saying the results are spectacular and you must wait b/c we cannot describe yet what we think we have. It is that good. Trust me. So, either trust him or move on, no hard feelings and no drama.
I'm good with that assessment.

How does one make SENSE of the Company/CEO's above INACTIONS, all the while actually taking these next 5 ACTIONS?:
(1) starting an SEC regulated insider planned stock purchases plan for public visibility about 6 weeks ago (widely acknowledged as a likely show of confidence by the CEO), and
(2) continuing to make positive unambiguous efficacy assertions such as "provides dose dependent cognitive improvement" and "restores cellular homeostasis" in scientific and investor conference abstracts and p/r's to date, and
(3) continue to proclaim as recently as the August 2017 SEC quarterly filing that the 3 trials have been designed and are first of their kind in precision medicine (see quote below), and
(4) deciding to use the 12 month charts from Dec 2016 in June 2017 (positive charts) with older data than what they had in hand at that time in June 2017, and
(5) continue to sign up for upcoming scientific conferences such as tomorrow's 2017 Healthcare Conference and the 11/13 and 11/14 Neuroscience 2017 Conference