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Reasonable to expect Anavex will announce MAA filing likely post validation. A decision to withdraw after clock stops 1 or 2, which happens mostly because the sponsor is unable to respond as requested, would be a material event and PR'ed. That or CHMP recommendation for approval likely about a year away, or less if clock stop 1 doesn't workout.
Let's see if there will be an MAA filing announced around the AAIC presentation date - would seem about the right timing.
Very good - hope you are right!
As you contemplate that remember the highly confident posts by Hoskuld and others regarding the Rett trial outcome and the best chances of approval for Anavex.
The longer we wait for new useful data the sooner we can update the chances of approval.
Meanwhile, some prefer to stick to 78% or 83% chance of approval and a stock price prediction well of $1000.
Your exam example exemplifies that you don't or won't understand the issue. You have a bunch students take the exact same exam in your contrived example.
In the case of EMA a whole bunch of companies are taking different exams across many categories of topics all at the same school. Several taking the Cancer, Cardiovascular, Dermatology, others in Endocrinology etc. etc. and several in Neurology of which few would be related to dementia. Looking across all those very different exam topics we get an overall conflated pass rate, which will not reflect the pass chances of one specific student in one sub-category exam.
In our case the student has proven very erratic with her homework often failing to hand it in or when handed in it is full of shortcuts and unsubstantiated conclusions, which does not bode well for her final exam results.
Not how a scientist thinks. Your reply is just an emotional display of confirmation bias.
You are truly a great biotech investor!
You continue to cite a conflated percentage overall for any indication, type of drug or other form of treatment as indication that your favourite investment drug will be approved.
You need to temper your excitement and remember to differentiate a personal opinion on a drug versus whether trial endpoints were actually met in an acceptable manner to the regulator. In this case allowing CHMP to recommend its approval to the EMA.
Just as we can't use the overall conflated EMA approval stats to claim the chance of approval based on the Anavex P2b/3 trial, one can't cite a single drug we don't like passing clock stop 1 as clear indication of a a pass for pet stock drug.
Hit the return key too quickly. Please go back to re-read.
Wrong! in the sense that there is no approval yet: https://www.reuters.com/business/healthcare-pharmaceuticals/eu-drug-regulator-does-not-refer-eisai-biogen-alzheimers-drug-meeting-notes-2024-03-22/
It goes to show that a drug passing stat sig through a CHMP review is no guarantee that EMA will grant approval. In the case of lequembi, I suspect the EMA may actually not approve the drug due to poor clinical effect vs. risk and cost.
Yes it’s not necessarily a negative.
“Perhaps that is not a negative that the EMA has not had many CNS indications which it has considered.”
The question though was paraphrased; why I don’t accept the 83% chance approval based on the topline conflated EMA stats.
I answered questions and added that i based on Anavex P2b/3 data and the company’s behaviour to date have doubts about their ability to pass clock stop one.
I also said I hope I might be proven too sceptical. I need more solid information that we seen to date before I might update my view.
Yes - the complex CNS indications are underrepresented in the EMA stats.
The stats you and others rely as representative of the Anavex chances in AD consist of a multitude of indications with an overweight of e.g. cancer, where risk/benefit is viewed with a very different perspective of eg. younger otherwise fully functional patients at risk of dying early.
One simply cannot take the topline conflated chance of EMA approval and transfer it to one specific indication and company like AD and Anavex.
If you go through the reason for withdrawal you will see that most were at clock stop 1 for the reasons that sponsor was unable to satisfy the CHMP questions and requests.
At this point I fear Anavex may be unable to satisfy clock stop one.
My opinion remains unchanged in that only an actual CHMP validated MAA filing that subsequently survives the EMA process clock-stop 1 would significantly improve the $AVXL price. Surviving clock-stop 1 is the hardest per the EMA published stats.
We can always hope that the July 28th AAIC presentation moves the needle. I also still have a sense that the AAIC presentation may mean no peer review published. If that turns out to be the case and the market waited in vain for the peer review 'catalyst', then only the MAA filing and its progress can help the price of $AVXL. Starting new trials is great, but will represent more cost for several years without revenue insight.
Let's see, I may well be too sceptical.
He doesn’t believe enough in Anavex to own Shares, hmmm!
Exactly!
Make sure you don't forget important zeros.
So is this guy gone?
More likely just weak, mediocre and useless pumpers not up to the job.
Georgejji is just wrong as so often before while calling others out for being wrong when they’re right.
I prefer proof without doubts. Hope we get some of that stuff 28th July.
I would certainly hope so!
“ We are likely to get the "full" results.”
Anavex can’t afford to continue making the same mistakes!!!
Yes 45 minutes and enough to deliver a solid presentation.
It would be great finally to get full clarity on the P2b/3 analysis results with all the required context and correlations to biomarkers.
90 minutes by our skilled SAB head should be plenty to deliver a good presentation. The key of course how good the results are and whether the analysis methodology is in line with what regulatory approvals require. The presentation 29th seems to be indicating that the analysis that presented 28th is per the new proposed methodology.
I would think the presentation will precede the long awaited peer reviewed paper, which I’m doubtful will actually be published unless we see it before July 28th.
I’d absolutely love to be proven wrong, perhaps this time…
Having read this: https://alz.confex.com/alz/2024/meetingapp.cgi/Paper/91799
I’m not too excited for $AVXL being say a $8 stock again just from proposing a new statistical method for making clinical benefits look better.
I will simply note that you haven’t caught the sarcasm in reference to the post stream leading up to your reply.
Maybe Leo can explain as needed, assuming of course he isn’t too busy smoking cigars while driving his motorcycle.
Kudos!
I've been told by an expert here that assigning 50% chance of succesful trial outcome is a non-committal coinflip and just as good as not assigning a chance.
A P3 trial was completed when the Accelerated Approval was granted based on the P2 trial. Based on that P3 full approval was then granted not too long after.
Too many confirmatory trials have taken too long to be initiated or even never started. To curb that the FDA has recently firmed up that a confirmatory P3 must be underway when AA is granted.
Right so we can only believe a biotech company has either 0 or 100% chance of approval - great makes it so much easier. Thank you for explaining that.
Probably less than you get for asking silly questions.
Your binary outcome sentence clearly demonstrates a non portfolio thinking and instead a pet stock single 99% chance of winning on a lottery ticket get rich approach.
That’s why I discuss chance of approval for folks to think about. Not as in influencing people not to buy or otherwise the stock, but just to think - apparently it isn’t well received despite also you getting your declared 99% winning chance proven wrong.
Now hopefully you own not just $AVXL or is able to lose again to be financially ok and just maybe wiser at some non zero chance.
Of course there was, as also pointed out here back when and now by the new Anavex larger trial design with equal sized placebo and dose arms.
I must be his handler calling him to more urgent work.
If read my post again you might find the answer to your question.
The words of the WGT crowd sounds very much like the kind of approach one might take to smooth over forgetting to sell and make a profit on $AVXL along the way at the obvious opportunities. The hope of course then becomes to repair those stupendously silly mistakes by inventing nice stories of imminent amazing news time and time again only to fail - few seem prepared to admit so.
Other more experience biotech investors who can read and understand the data and statistics presented, like me, becomes sceptical about a biotech that miss pretty much all their self-declared catalysts and make false or non-sensical data releases to appear impressive, but lack context.
I will change my sceptical tone if and when there is clear and meaty PR from Anavex moving the company tangibly towards revenue. Of course I own shares and comfortably so at negative cost and hope to gain even more, but from fewer shares than I once owned. Still plenty to be grateful for even more payoff, should that be the final outcome.
That was much later and clearly confirms that not all endpoint were met or else Anavex wouldn't have needed that PR snippet you reference.
Please pass on my acknowledgement to your wife. You are fortunate to have a level headed partner in your life.
As I, I am sure your wife also hopes the $AVXL investment will ultimately bare fruit...only even more time will tell.