Replies to post #506816 on Anavex Life Sciences Corp (AVXL)

[sage4]

Wow you have a big picture; I mean immense!!
Appreciate your 3rd post on this board.

[Investor2014]

You frame it well and it makes a lot sense.

It also means that Anavex will need to put forward a factual and clear defence for the data gaps, size and length of the trial and the in-trial subgroup hypothesis.

I strongly suspect it will also be questioned why Anavex decided not to run a confirmatory RCT in parallel with exploring regulatory pathways (EMA MAA).

I’m still expecting, or perhaps rather hoping for, a conditional approval with a RCT to confirm this new class of treatment is the real deal!

Making it CMA is also a less categoric step for EMA avoiding any later potential controversy.

[AlchemicalVoyager13]

BY FAR.........the best and most logical, informative post on IH I have read. Thanks. I think this will put many "at ease" for the next few days, including myself.

[AlchemicalVoyager13]

@ Investor2014 First, are you British? (defence rather than defense)
I firmly believe that a CMA will be green lighted. The EU can not afford to have this drug available to the masses and furthermore have approved two others with far lesser efficacy at a high cost/patient. I believe the 3-4 year OLE serves as an additional P3 trial without doubt. And it had patient benefit of no placebo.
To not approve Blar will cost member countries billions upon billions in additional patient care expenses per annum. I realize that is not in the forefront of the decision making process but is reality.

[sab63090]

Gravedigger1

Maybe you have forgotten that before Missling filed for MAA he was prompted by the EMA to file and had all of the data.

Missling was quoted as saying exactly that.

I believe that the two rapporteurs at CHMP are from the EMA, not certain, so if that is true....the questions might be pertaining to ad hoc information, not sure about this either....but maybe limited to how prepared Anavex is to bring 2-73 to the potential patients (marketing)...

I see you have quite some recommendations....especially after the child asked Mom to go play outside with friends and she said to ask your father.

[flsh56]

Missling also responded to "why the EU submission" and replied because the trials were run there (AUS & CA also). What are the chances that the EMA fielded requests from outside the trial participants for the medication. Could word of mouth on efficacy spread around through loved ones (#friendsandfamily). Hey anything is possible. Godspeed to the team on this meeting in progress with even more convincing data of late. So this tiny baby bio consisting of 42 employees is at the doorstep at greatness. Perhaps the CHMP has concerns more about execution of an approval. Sandra certainly isn't going to count scripts. I would feel that all must be clearly defined, manufacturing, distribution, (reimbursement structure), patient and medical professional support/education resource portals, etc, etc, etc...

[rayovac812]

Incredible insight Gravedigger. I hope this makes the rounds across many boards. I can't keep up with all the posts here and saw this elsewhere. I wanted to find it here and comment. This could have been an published article. High kudo's to you.

[jfk]

Awesome post, which frames this moment in time so well, while our investment is thoroughly crushed.

So the timing and investment implications would be what in your opinion? What strategic paths would be considered in light of this long/longer/much longer path, ie, partnering, etc. What do they do in the interim, while the board studies, studies more, and interrogates? Like you indicate, they will not be motivated to consider any timetable, other than ultra caution, in their approach.

Looking forward to your response. Thank you.