696,193 is close enough to 10,000,000 for some. Sort of similar to meeting all endpoints even with a failed co-primary one and almost nearly maybe filing an MAA last quater.

You seem to be implying that A2-73 can work in (I assume considerably) more patients than 20%. From what other than hearsay and wishful thinking do you get such claim and why would that contention make regulators more inclined to approve?

First Anavex will need to show that the trial results were statistically significant and clinically relevant. Many incl. Anavex claim so, but based on a number of assumptions that we have yet to see a regulator consider. That requires an application filed and validated, which we have yet to see. If the one primary and one secondary endpoint met with a < 0.025 p-value is in the SAP and the regulator is willing to pursue that, then that were more hopefully objective biomarker data can be useful in supporting some form of approval.

Way too much hand waving, cheering and believing in 83% chance of approval way too early imo. The price of $AVXL would be higher if more than few on he MB posters believed in an 83% chance of approval.

There is big difference between screening out patients for a trial vs. dropouts from a trial, but I guess you are just ducking and diving making up new arguments as you go.

We are yet to see any subgroup analysis, but we already know SIGMAR wt vs. variant makes a lot less difference that indicated by the P2a very small trial analysis.

What other factors will be confirmed, falsified or if any new ones pop up, we don't know yet! As I've been saying, its why we know Anavex are working on that and Missling have hinted he feels its exciting. Missling is always much more excited than he think investors are - the reason has been shown consistently by every presentation of data to date!

This investor needs to see hard core data proof and I'm not sure we will get that from the current trials.

So more that 4.5m to go is the last few hours on an option expiry. Certifiable!

I have a feeling that $AVXL will end on or near the low of the day on close!!!

Probs buy $AVXL for less than $6 next week, but I can wait probably almost to Feb'ish.

The FDA have not and should not have any issue with inclusion/exclusion criteria for a clinical trial, even if it means 70% of the patients population is screened out. For example selecting only patients with PET indication of plaque etc. That won't affect the statistical outcome of the trial since all patients, drug and placebo arm, will have a close matching baseline.

The wait is imo the hope of strengthening the overall findings incl. OLE results with correlations to biomarkers, including across the pool genes with altered expression associated with PD and AD (70% overlap). If these and Sigma-1 as well the other prespecified biomarkers are showing more normal levels after exposure to A2-73 it gives hope.

This will likely take a while, as before, to process from the OLE and to then to run the many correlations across the trial entire dataset. If those objective markers show clear correlation to the top level results Anavex is trying to claim from completers only it could potentially provide enough evidence for EMA to provide a conditional approval and likely with a label targeting responders.

I would assume this is also a key part to the long awaited peer reviewed paper - have they filed one yet?

I know - let’s see how it goes. Anavex will need more supportive correlating data. They are working on it and delaying the MAA filing either because the CMPH have told them more is needed or they are just taking longer…

They failed trials in main CNS diseases with their Sigma-1 agonist, so they try something else.

Since the P2b/3 was not successful per original endpoints and SAP as defined, Anavex needs anything and everything that can help to show plausible evidence that A2-73 has an effect in AD patients that outweigh the risks.

The alternative is to run a larger confirmatory P3 designed to iron out the titration issues, show a dose/effect relationship that isn’t just ChatGPT generated and perhaps enroll on certain subgroup criteria that we are yet to see data on (gene expression etc.) - you know the precision medicine thing.

For now it seems penny wise pound foolish Missling is stretching things out to see if he can wing it with EMA.

Test

Yes but you see for the price to go up demand has to outstrip supply, which isn't happening despite all the assurances over the last number of years from Georgejll about that short squeeze being just around the corner.

No one is wanting to buy here. The longer we wait the sooner $AVXL will be cheaper - maybe until Feb'ish.

That is undoubtedly true and almost as much as the EMA would consider what say Georgejjl, Catdaddy, Ohsay and all their cousins might think.

Let's hope EMA is now using ChatGPT to handle their approval process analysis.

Even if I wanted to, your logic would be impossible execution and besides I’m staying to at least Feb’ish to see if TDG gets his finger out and files an MAA.

According to Eikon ownership reports that is correct, all Vanguard funds holding AVXL are Index Style funds.

Sold half at around $5’ish for about 50% profit looking to buy back lower awaiting NDA filing and like decision dates for Reproxalap.

Where might $AVXL be by Christmas with no MAA filing in sight?

You have found the most entertaining bio mb I know of and I suspect you may be able to contribute.

Just look at all the emojis.

lol! That kind of statement can be applied to absolutely anything with equal weight, which amounts to about nothing.

The chance of anyone being pay to post here is infinitely lower than the chance of A2-73 being approved even from current trials.

Awesome stuff, especially the last bit.

Got my 1st daughter staying for a while as she finds her feet in Denmark after relocating from the U.K.

Its hard work for just a 17% chance of being right 😁

In a new trial it might if the OLE and compassionate use patients reliably show that.

Bottom line is that Covid wasn’t to blame for the TEAE discontinuation in the P2b/3 trial as we clearly see in the data Anavex published.

Probably because they were on placebo.

Did BSIG pumping help NWBO to be a succesful biotech and investment?

lol! So no one can find or invest in companies without using a message board as their source of information.

As some will know I have had an inkling for a number of years that we are seeing another Madoff mind in action. There is just something about the pattern displayed over the last few years that makes the chances maybe as high as 83% for Madoff vs. TGD, imo.

Really hope I’m wrong and the WGT lot is right, only even more time will tell…

An already on the way confirmatory trial is now what the FDA rightly expect before granting Accelerated Approval. There is at least one issue going at Anavex holding them back from starting new Rett and AD trials, which is likely some doubt that A2-73 is the drug to spent money on.

Sounds logical.

A paper on 20 completers from an ITT of 132 would never be peer reviewed.

Me too.

Only 120 actually started the main trial.

Great! That makes one not surprised and content $AVXL investor.

Indeed but less than 60% of the original trial size.

Do you update your $AVXL profit and dividends spreadsheet as often as the TA guys, or do you reckon there is longer between you getting it wrong?

Or Feb'ish.

Is that with or without the Anavex factor added?