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Sounds like the ideal venue.
Hopefully Anavex will be using a cheaper placebo pill in the next studies.
Yes it is great article that I posted here a few times some years ago to the usual reception such as, there is no placebo effect in AD, Rett, spinal court injury patients etc.
I find it an honour and absolute delight to be on the Sparky list. Was hoping to see you there soon 😀🎉🥂🍺
You have a chance of making into the bottom rank of the list now.
Were those the EXCELLENCE 99% WGT calls?
Can't imagine being bored with all the entertaining posts here and thank you for your contributions.
Hey Georgejjl, that fantastic $AVXL news you announced would come this week will that be after hours today?
Waiting for the announcement of more dry powder wasted.
2nd Jan with only this: "Anavex Life Sciences Provides an Update on Rett Syndrome Program", no full TLR yet!
Anavex still have time to meet Feb'ish, if they can provide an update on regulatory action with full TLR. So unfortunately my prediction is the best around. All the others were from folks here predicting a slam dunk for EXCELLENCE being announced last year. That didn't happen!
Foggy memory perhaps.
It could have, but not for AA and instead full approval as per the Anavex PR - PUMPER!
It can, but Anavex haven't submitted the MAA. By the time they do, it will be impossible that the final opinion will be this year.
First it doesn't appear that Anavex at this point based on their PR had requested AA.
Don't you understand that the same two clock-stops are also part of the AA pathway?
Do you understand what it means when EMA says:
PK/PD = PharmacoKinetics and PharmacoDynamics
The evaluation of medicines, step-by-step
Lol!
Sort of planing to plan something once there is a plan.
Seems a contradiction in terms,
They might, but then it would be bad.
Anavex will not enter Day 1 of the EMA process until the MAA is filed and the checked for completeness.
11+, but for Anavex or just in general?
Is that why you expect EMA approval this year?
For those having trouble understanding how far Anavex have gotten with EMA MAA filing - we haven't even got to Day 1 yet of either the AA or normal CHMP process.
Sounds good bas. What was IR's comments on this.
You do realise how unlikely it is that Anavex won’t get a single comma wrong in 100,000 pages, let alone not missing or incorrectly / insufficiently presenting some data or conclusion from it - something that has already happened a few times in much fewer pages.
I doubt that many MAAs will go straight through without ever touching the walls within the CHMP offices.
But of course you just had to make that remark.
It would be very unlikely the CHMP have no comments, but we can hope they are easily resolved in a matter days. The EMA stats says to expect about one year for the average end to end review process.
Leave it to a paid pumper and Missling Apologist to spin anything and everything Anavex hyper positive no matter what.
It is part of the link I posted, but I guess you didn't read it and just followed your script disregarding any remaining integrity you are unlikely to have.
Just to be fair with integrity - I agree with this.
The evaluation of medicines, step-by-step
You are elegantly 'forgetting' the two EMA process clock-stops, where Anavex could take ages to provide answers to EMA feedback and requests for more information.
I may be too optimistic !
And the Anavex timeline heading has stood still since 2022.
And that's for a biotech company...
Not quite, but good try!
That I am not in the least surprised by.
I take it that means you do feel better now and good for you. You are welcome.
Based on what we have seen, I’m making a perhaps incorrect assumptions that there is a large patient dependent spread of tolerable doses.
A3-71 appears to have an even larger dose range that A2-73 and perhaps associated with levels of S1R expression in individuals.