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I get that (as you well know) and my original point stands. This is, the FDA guidance will have zero influence on the outcome of the class action case against Anavex!
ORDER SCHEDULING AN INITIAL PRETRIAL CONFERENCE
Worth noting.
Let me first remind you of the post I originally replied to.
That catdaddy uses every opportunity to display his ignorance is expected, but you should be able to understand and accept that my word usage wasn’t part of the point made in security class action law.
What I said applies just as well to the initial litigation as it does if the case goes to trial.
You can read my reply to catdaddy for further detail. Put your WGT bias aside and try to be the brilliant lawyer you are, then tell me how some new FDA guidance changes the merit of the case one way or another?
Well Boi seems to object to the word “trial” that he puts a question mark to.
There are “trial”steps in progress in the case made by the “complaint” filed. The summons just served on Christopher Missling.
Now that case may be dismissed, it may reach settlement or as very rarely be determined by the judge and even more rarely in securities class action by jury trial - although jury trial is almost always requested by plaintiffs.
Neither of those outcomes will have anything to do with any new guidance that may change future prospects for Anavex.
What matters is the alleged wrong doing at the beginning of the class period and until the truth is revealed towards the end of the class period with the final cited disclosure marking the end the class period.
The cause of damages alleged, if not dismissed, are the basis for the case and not what happens after the class period, like say the new FDA guidance making future drug approvals more likely in some circumstances.
A post class period event won’t eliminate any damages to investors that held shared during the class period, except if the stock price for any reason recovers during the 90 days lookback period. If the price of $AVXL does increase in the 90 days post the end of class period great, but that doesn’t seem likely.
I don’t think you understand what you are saying.
The FDA thing will have no influence on the trial one way or another for the simple reason that it is an event that falls outside the class period.
I guess I wouldn’t either if I was 100% certain there is an 85% chance of AD approval in 2025.
We will see, but I am not talking about a short term pop but a sustainably higher $AVXL stock price.
Yes and I will be right as usual.
Scizo trial gotta enroll first and all the other stuff before Anavex gets round to publishing results months after the data is in and its only a very small P2 trial to work out dose, so no.
Filing the MAA would be great, but not the price increasing and sustaining news we need. Approval would be and if that happens it will be well into 2025.
Unfortunately no! I did have the privilege of watching thousands of GPU manipulating the $AVXL stock price to time my sales and purchases anywhere near as optimally as a fireman would.
Can't trade derivatives in my UK SIP pension plan.
All my handlers are supplied by the pumpers and clown emoji warriors.
Well its been 10 years so far and counting. Luckily I did the pension biotech portfolio management myself making sure to sell $AVXL at every irrational price spike with not even a trace of FOMO.
Right so not Alpha to be fund in TA.
I’m glad you are not managing my pension fund 😀🙏
If you hold that thought, then contemplate what you said one more time.
Reality and the market currently disagrees with you. Maybe that will change and if it does it will be over a year from now.
Stories made up to fit a narrative, while possible are far from likely to become reality.
I can’t believe how much nonsense is being posted here. The reason for the $AVXL share price is that the two key trials that investors were hoping would succeed didn’t!
Maybe there is a hope of approval from the AD and Rett trial mixed results, but the Anavex story is no longer the one it was and it isn’t clear if it will be again.
Yah! The PDD trial data peer reviewed publication has been in the wings for over 3 years now.
It was 91% of eligible patients coming out of the main trial, that is minus dropouts and those that for other reasons (exclusion criteria) are no longer eligible for OLE enrolment. The 93% is of however many completed the OLE so far opting for SAP access to A2-73.
Lol!
Now we just need ohsay to chime in with some 'intellectual' attempt.
Some evidently still do.
I just want to take a minute to congratulate the handful of emoji warriors for making those as meaningless as their posted words were. On the bright side, for them, at least using the emojis puts less strain on the critical faculties.
Don't you think that perhaps that is why I said:
No there is isn't!
Once you are living in a cardboard box in an underpass, I don't think the law firms will consider you as representative of the class.
Better follow the actual case here:https://www.courtlistener.com/docket/68337947/blum-v-anavex-life-sciences-corporation/
Reading this Q&A from the Q1 2024 cc, it seems more than likely a new Rett trial will be required. Although of course Missling does, as he should, leave open the possibility of approval based on completed Rett trials and OLE data. Hard to assign chances of approval in rare indications, but I would say perhaps 25% chance of some kind of approval - perhaps not from the FDA first, as there was no EXCELLENCE patients enrolled in the U.S.
It has by just 8% of the overall insty ownership being non index style funds.
What do mean “There is no ‘endpoint outcome’ measure.”
Of course there are and in the PDD it was a battery of tests not all reported on.
Hence the PDD trial was named a “Proof of concept” and precious little has happened with that indication since for now over years.
Yes as I said “at least” a year.
Ohsay if I recall originally got upset with me saying Anavex needed to publish convincing news to sustain the $AVXL share price higher. That was some years ago now and we still have more than year ahead of us to maybe finally get that kind of news.
The two possible events you mentioned won’t be that sustainable $AVXL price news needed.
Same place as we find you, otherwise what would you do?
What - not reporting on all endpoint outcome measures is not a trial fail?
Similar to the fact that not reporting ADL in P2b/3 trial per protocol is not agreeable with a 'met all endpoints' statement. As others have observed meeting all endpoints is not always a requirement for achieving regulatory approval, but it helps a lot!
Also look back to make sure you understood the context.
Well indeed.
There is securities class action case on the go, that's a bit of news we haven't seen in while.