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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.
This is a documented straightforward fact, which also means that 92% of institutional holdings of $AVXL is in index style and passive funds with no manager reviewing or in any way have an opinion on the merit of the company’s drugs.
You obviously have not recognised that no news event from Anavex so far has been an unquestionable pivotal success moving the company close to revenue. The slam dunks have been absent, but some form of good news from currently concluded trials could emerge at some points. More likely also news of more trials needed. The price of $AVXL reflects those facts.
Well we could do well by using the exclusion principle first to narrow down the candidates.
There are potential parallels, but would have been nice to keep Selena around.
I perfer Selena Lopez.
Not surprising when a Patreon sponsored hobby analyst that the WGT crowd look up to can predict a $6,000 price tag on one $AVXL share. I mean most WGT nonsense here is fairly innoxious in comparison.
Indeed it is pretty simple.
There is just over one thousand followers of this $AVXL MB, most of them not posting.
The delusion runs deep here among a certain relatively small group of ‘investors’ and emoji warriors.
I still think there is merit to A2-73 given more time and like more trials.
Must be a few kicking themselves for not selling on irrational price spikes seeking to justify their losses by blaming the boogeyman and some here with a better grip on reality.
Well that sounds really convincing, lol!
But you know?
No some people just better understand how to and not to breakout and interpret that 85% figure and what it represents.
I don't think the CHMP have been fooled, but some have into thinking there is an 85% chance of approval.
All we have just now is an agreement that Anavex can summit an MAA. Now we wait for that to happen and for it to be validated as the first step towards eventually learning if A2-73 will be approved in AD.
Meanwhile, the fumble topline readouts of the P2b/3, AVATAR and EXCELLENCE trials is what we've got and that is reflected in the price of $AVXL.
It is in fact that simple and straightforward!
Amazing how deep flawed thinking can run in the absence of understanding the simple facts of failed topline clinical trial readouts.
Too subtle for you perhaps?
There's no reason either why Anavex should time so many 'catalyst' events with high expectations and excitement only to never deliver or deliver up to years delayed.
There will need to be one distinct complaint and class period defining a securities class action case. The first omission or misstatement (later revealed) marks the start of the class period. There may be further related later disclosures before the truths is revealed. Revealing the truth may and often do have related events, where the last disclosure marks the class period end date, which must also be associated with a stat sig priced drop as compared to the overall marker and appropriate sector. The class period dates are often changed from those in the initial complaint through amended complaints as more information comes to light.
In principle two different complaints making a distinct claim and with different class periods could be filed about the same time, but I have never seen that in practice (having reviewed a ton of cases to define requirements for a system that among other features automatically track and organises related cases). I suppose an argument that both the Anavex Rett and AD trials share a common claim of misstatements and or omissions is possible and unfolding over an extensive class period could be made, but they would need to be of exact same nature and related.
Again we will really only know how this will develop until after 12th May, when we know and have read any and all motions for lead plaintiff. There is a first for everything, as they say. I would think though that any joiners will be around Rett given the endpoint change debacle, whereas the AD situation is just mixed results and not unexpected or 'hard sold' otherwise by Anavex (except for the all endpoints met statement that is hard to see how could be true but can be flavoured).
"In this case", good so now we have established that a categoric statement wasn't correct. It was only to be understood that it is your likely correct opinion in this case.
Now let's wait for the 12th May and seen what then happens. What are your odds that no other parties join through motions for lead plaintiff?
You still have to wait for the 12th May lead plaintiff deadline like everyone else, but those who might intend to file just before the deadline.
What are your odds on no one else filing a motion for lead plaintiff, 85%?
Oh and i can concede that discovery is automatically stayed once a motion to dismiss is filed, but not that discovery can't take place before a motion to dismiss is filed.
Have a look at this easy to follow, but somewhat simplified, flowchart and note the text in the Motion to Dismiss box.
You join the ranks of those who really don’t have clue about securities class action and erroneously believe something underhand and irregular is going on.