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No that quote I took from the 2018 article, read that article again!
If you have also found the same quote from a 2021 article you have helped yourself understand what I told you.
You said:
Hint! Retrospective!
I might consider a review if you make a start on apologising for all your nonsense and misleading predictions, your lack of understanding set theory and your endless pumping.
Did you retire from the federal conspiracy agency?
Its certainly not the first time you have been found to be wrong, Georgejjl!!!
Georgejjl, the article link you posted is from 2018! There was no P2b/3 AD trial back then, duh!
Another blatant super pumper lie!!!
I said nothing significant! A3-71 results of P2 PK dose finding trial won't be significant in terms of $AVXL as an investment.
That's probably going to be the next time $AVXL takes another major nose dive.
There is no fear of missing out on anything significant in over a year Georgejjl!!!
Whats up D-Mike, lost the $AVXL WGT mojo?
Another opportunity for Missling to tank $AVXL. Can't be bothered to listen to it.
Law firms will keep advertising for plaintiffs until close to the expiry of the lead plaintiff deadline - Its what they do! The reason being that the Private Securities Litigation Act (PSLRA) stipulates a lead plaintiff deadline to ensure that if, there is ultimately is a certified class it best represents all those damaged.
Great if no one else shows! Then we can pretty much close the book on this case too, especially so given the last court order, so just let it ride till 13th May.
Missling spoke and as expected is reflected in the $AVXL price. There was no tangible news of any progress, just more 'promises'...
Ok then you get second smartest post of the day for copying and pasting the link.
Folks could simply go to courtlistener.com and use the site to get even smarter.
Smartest post of the day!
Be smart and copy paste the link to some scratch pad so you can see it!
As I said RECAP is a plugin for the CourtListner site that recaps dockets downloaded from PACER to the site.
From the courtlistener.com RECAP archive, which you would know if you had looked at the URL. Same site as I have previously referenced.
RECAP means that someone with PACER access used their logon through Courtlistener and volunteered a copy of the docket to the site.
Yes interesting scribbles on the docket. Likely by the court/judge, since RECAP is plugin that directly copies the docket from pacer to courtlistener.
Good move by K&L Gates on behalf of Anavex: Re: Blum v. Anavex Life Sciences Corp., No. 1:24-cv-1910-CM
Essentially there won't be any case unless further parties join through motions for lead plaintiff within the 60 day deadline. Anavex can then wait for a potentially more coherent amended and consolidated complaint before having to respond, or never respond if no one else turns up and the case is dismissed.
As I previously mention if no one files a motion for lead plaintiff, its a good indication that the case has no merit.
The longer we wait the sooner A2-73 will prophylactic.
Missling has just been reading this MB and picking up things that will please when mentioned. There is no real evidence that any FDA filing is eminent. As usual what he said have no deadlines. Even if it had we know how unlikely it would be that a catalyst expectation was met with any normal margin of error.
I no longer and haven't for while now believed anything Missling says about catalysts and Anavex trial success. Looking increasingly more like Madoff than TGD to me, but oh how nice it would be for once to be proven wrong about Anavex.
Unfortunately Anavex have not yet filed any regulatory approval applications!
Results count!
When Missling speaks there is always action!
Yeah Rett would save the day, but since it now won't AD is the new 85% chance WGT hope. But AD too may need another trial probably with A3-71 in years to come.
If Missling truly is brilliant, there are times when it can be hard to spot!
That another Rett trial in needed is not news to anyone but the WGT crowd.
Not the recent transaction but countless over many years achieving absolutely nothing other than investors loosing money.
I didn't hear any nuggets, did anyone else? Sounded like same old trying to keep a relaxed pace.
Maybe she just got out of bed?
You may be right or you may be lulling yourself into a false sense of wgt.
Lots of great biostatisticians and other experiences employees have joined companies that both fail and success over time with drugs and different indications. Failure to get approval could still happen even with the best of statistical finessing, simply because the results are not strong enough.
I think there is a chance of approval from the P2b/3 AD trial, although at present I can't say how small or big because clearly the trial results were not a 'slam dunk' at all! Assigned 85% chance of approval is foolish at this point, as I and others have explained reasons for. The chance of approval will improve the further through the CHMP process we advance and can be assessed at each point as more information becomes available.
Its good that Kun Jin is there to navigate the statistical avenues. Ensuring solid SAPs and influencing future trial designs for appropriate statistical power etc. is an essential capacity to have for a biotech - Anavex clearly didn't have that prior to Kun Jin joining.
Kun Jin will likely still have his retirement job at Anavex if A2-73 fails to get EMA approval and will be working on other trials, whereas WGT $AVXL investors might have lost more money.
And the perfect test is underway or perhaps even more remotely possible, not really. Either way the outcome will become known.
And you don’t think that it is even remotely possible we are looking at pig with a layer of WGT looks cosmetics?
I'll defer the AD stage and ADL outcome measure technicalities to Doc.
My simple take is that if/once we see an MAA filed and validated by CHPM, then pass clock-stop one of the EMA process a new situation is established, where A2-73 will likely be approved in AD without ADL being a crucial co-primary endpoint concern and with an acceptance of the overall effectiveness of A2-73 on biomarkers, safety and efficacy in some yet to be identified/revealed subgroup of patients.
All this may be about a year away and is a really good test for Anavex as an investment grade company and its future. I think people can and will make up there own mind as to the prospects if an EMA approval is not forthcoming.
In this new situation with the new FDA guidance it would make sense then for Anavex to file a well prepared NDA around the time of the EMA clock-stop one pass, which the FDA would then in turn likely approve. I don't expect to see parallel filings, the costs of those and the risk of multiple rejections being a possibility.
I wouldn't expect any wonderful developments or peer reviewed paper to accelerate approval hopes outside clear progress with EMA.
If its gambling then its a bad bet, always have been always will be imo. But the guys behind the operation continues to live fine of of other people’s money.
If Hosai does appreciate that great, but then it should be much clearer and not perhaps implied across two paragraphs.
There are a number of posters here who clearly accuse the FDA of ignoring Anavex or worse being in collusion with BP to hinder success and approval for A2-73.
It is a simple fact that no FDA determination of A2-73 in any indication will or can be made until Anavex perhaps get round to filing an NDA. The first such regulatory test may be from EMA, if and when Anavex actually files an MAA and then first have it validated and then onto CHMP review, then clock stops and acceptable responses from Anavex and on from there with a recommendation for EU approval. You know that 85% chance of approval thing through that whole process for one specific CNS drug and indication.
The FDA is not ignoring A2-73, they don't have anything to evaluate until Anavex might file an NDA.
Yes not looking great on the surface, but might workout - as always only more time will tell if approval can come from currently completed trials or we need more.
The $AVXL story is one from which a biotech investor can learn that a PR and results can at first glance appear WGT, but are objectively not. Then adjust approach with a willingness to learn instead blaming the boogeyman. Use the experience to know irrational price spikes when they happen and sell at least some of a position to own the rest at lower risk of losses and by all means keeping doing it while keeping a balanced portfolio. It takes time and disappoint, but it is a learning process to go through that can make biotech investing fruitful and exciting especially when a drug or treatment that truly helps people succeeds.