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The Anavex stats on how soon after trial completion we see TLR are not good.
What is good to see though, is that the trial design takes into account three things that the company have now learned and investors have complained about.
Underfunded? The FDA charges $4M vs. EMA EUR0.5M for accepting a NDA/MAA. So by implication the FDA can afford 8 times more staff than EMA and process the application in no time compared.
Just a question of...
Below is what ChatGPT has to say about:
Probably need to be at or after the 7 months point given that the Anavex PR claims interaction with CHMP.
Anavex can't, but they could have issued the PR at the end of that 7 months period instead of at the beginning. That would then be the reason back in Q1 of 2023 that Anavex were talking about aggressively pursuing approval paths.
So can I have that first place then?
Why can I not have the first place? Seems really unfair!
Yes and it would be a backup in the case as you say the A2-73 program was a failure. But I was more specific referring to
I did not say it was.
Yes because it is true statement of fact. Nothing more and nothing less.
I just want to know when $AVXL will be an $8 stock again?
For a good while new trials will be another line of expenses that could become a catalyst in years to come. Without or until approvals and revenue we should not expect $AVXL to become more valuable.
There we have the first backup continuation for Anavex and Missling just in the, unlikely of course, case that no approvals will come from the P2b/3 AD and EXCELLENCE Rett trials.
Some posts are so lame that they aren't worth replying to. Yours on the other hand are so eloquent and well thought out that they deserve my attention for a few seconds.
It also pleases me that I can help you and others to a few likes from catdaddy and that lot.
I see you have shifted from counting and logging my $AVXL trades to instead counting my posts. I really appreciate your efforts as a part of your otherwise many busy and prosperous activities.
Are you up early in eager anticipation of the amazing news Georgejjl has promised us?
Publishing the PDD peer reviewed paper, initiating several trials and other 'catalysts' was also the company's words that after about 3 years still haven't happened -were those words also true?
If Missling is in fact the only employee and all the others we've heard of are bogus, then probably Missling should concentrate on the MAA.
Exactly we know that some folks will simply claim any Anavex trial is great despite it being fail.
Let me ask you, do you reckon all endpoints were met in the Rett EXCELLENCE trial or was it merely successful or worse?
Exactly that is was clearly stated and committed to in SEC filings by Anavex, which is described by less categorical phrasing such as “the trial is successful, if…”.
So perhaps you are beginning to see the point I’m making or is that too much to hope for?
In principle yes there could be a class period from the "met all endpoints" statement with 8-K filing and until a clear disclosure that all endpoints were not met, within which some investors would be damaged.
However, for that case to be successfully made the end of class period date (determined by the last disclosure) would have to be associated with a statistically significant drop in the price of $AVXL. If the disclosure that all endpoints were not met per protocol comes at a time when the market is expecting approval from the totality of data or approval is announced, there would be no end of class period price drop and no case.
Saying things like "the trial was successful", met is objectives etc. are open-ended statements, whereas saying "met all endpoints" is definite and specific.
Anavex have already, if not directly said, clearly implied that the ADCS-ADL co-primary endpoint was not met.
What do you think these sections might contain?
Pretty sure you already have a well used dartboard, I suspect with a fairly intact bullseye unless of course you belong to less < 15% that consistently hit it.
That paper, if worth its salt, will also establish that the ADCS-ADL co-primary endpoint failed and thus that the all endpoints met statement was false.
Anavex and everyone else but the class action lawyers can now hope that approval and/or some other reason results in a share price increase making any action moot.
I don’t think we will see that peer reviewed paper until Anavex and their lawyers feel certain that the risk of litigation has hopefully subsided.
I suspect Feb’ish could be a little too optimistic, but let’s say H2 2024.
Obfuscation is on the part of those unable or unwilling to understand how to interpreted and apply the EMA published figures without provide sound reasoning of their assurances. Those, include me, that do not agree with the an 85%+ chance of approval have explained the reasoning behind why we can't (and the market don't) assign anything like 85% chance of approval.
To then accuse me and others of being against Anavex and approval is a falsehood and childish binary discourse. I for one would love to see A2-73 approved from presently concluded trials and would be very happy for patients, their families, caregivers and investors. I do believe there is chance, as I have said repeatedly, from the totality of data coupled with safety profile and the unmet need. They only difference we have here is how as biotech investors we assess the chances of approval based on what is and can be known at present.
As I and others have also pointed out, regardless of whether approval is gained or not, we will never be able to settle if the 85% vs. 15% case was the right one - nor does it matter, at least to me. No matter the outcome we will have a new datapoint on what it takes to gain approval for a new substance in a hard to treat CNS disease with little or no effective treatment.
Are you 85%+ sure about that?
Doesn’t look like the market has calculated into the price of $AVXL the official EMA statistical 85%+ chance of A2-73 being approved for AD.
The cabal must be bigger and more powerful than even BSIG ever expected, cause there can be no other explanation!!!
Are you feeling better now?
Anyone can choose at their leisure to ignore what I wrote in post# 447664 and what Doc328, Joseph, Steady and Froll has said. We all hope for the best and their is a chance, but I just don't see it being as high as you, Boi and the WGT crowd would like.
Yes clearly a simple mistake in completing the form.
It would be fantastic to see EU approval for A2-73 in AD from the P2b/3 trial - no matter the various assessments of the chance at this stage ranging from the fantastical to none.
I and a few others outline rationale reasons why at this time it isn’t an 85% chance. If it was that certain and so simple to assess with an 85% certainty of approval for an AD drug, it would be highly unlikely that only you had stumbled on data and a reliable calculation for that level of confidence, as it would have been reflected in the price of $AVXL.
Statistics is not intuitive and as minimum require that all the inputs are relevant and correctly understood for any hope of choosing the right calculation method to get a sensible result.
Another 'experienced' investor and then in biotech.
Anyone who actually care to read the stats being refereed to, take a deep breath and think, will find that they are an amalgamation of treatment type, type of enabling technology and indications further marked by whether a new substance is involved (as apposed to a known substance approved already approved in another indication). A big pile of vary different circumstances.
Very few drugs is are in each indication and in CNS and specifically AD in 2022 there were none. Furthermore A2-73 is a new substance never approved for anything by EMA or elsewhere. All of this is the biggest reason that the silly idea of 85% chance of approval for A2-73 in AD, only because EMA has agreed to evaluate a complete and correctly completed MAA, is just complete fiction!
There is a chance of EMA approval for A2-73 in AD, but it won't be anywhere near 85%.
But but but it is a statistical fact that there is 85% chance I will get rich no later than 2025 cause the EMA said so and when I see 85% from EMA it means 85%! You just want to pee on my sugar sandwich.
What you are describing is not a sound way of being a biotech investor.