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Which is why we can't just assume that Anavex lands in the 85% approved bucket and not the other 15% one.
Yet they were recommended by EMA to file a MAA. How could that happen?
What do think characterises those applications that ends up in the 15% bucket?
I already told you I sold at higher prices and now retain a smaller position in the hope I’m undervaluing $AVXL.
I guess you are just a bit dense.
Well no sane person can keep up with the American conspiracy and irrational theories posted on message boards.
I’ll just leave you to believe and think anything you like, makes no difference to me.
For what it’s worth to you and I have said several times here, I never have and never will short any stock, one because I don’t like the idea of risking to lose more than I put in
Even if I wanted to short, but I don’t, I can’t in my UK SIP pension fund nor short US stock with my DK brokerage account.
You got that answer too implied in my previous one. Are you buying now or have you no dry powder?
I have been a $AVXL seller many time at much higher prices than now. You?
I think you are likely overvaluing $AVXL and I hope I am undervaluing it.
You can assume Day-1 is passed with 100% chance, I will still wait to see it happen. Hope that's OK with you.
Clock-stop 1 and then 2 are of course crunch time, where the applicant can take time out to respond. To get there, as I said, the Day-1 validation of MAA completeness must pass. So post Day-1 something actual towards a potential approval is happening and is the first time we can apply a Bayesian inference update on approval chances and do that again after clock-stop 1 & 2.
At this time we can't even be sure that Anavex will actually a MAA, just like we haven't see several other claimed expected catalysts happen. I choose to not hold my breath, but wait till I see them happen and then adjust my view.
Yes of course it is a prerequisite to file a complete and correct MAA in the first place to even be in with a chance of approval.
This is why I want to see a MAA filed and pass the EMA process Day-1 validation before having a view on chances of approval.
You sound capable of looking up the data and the categories the overall approval stats apply to. They are very cause and do not for example breakdown into CNS and new vs already approved substance drugs.
Let me know if you can find the data.
PS! At least boi used the overall approval rate that takes into account never filed and withdrawn MAAs.
Fortunately for me I have no plans of applying for anything at whatever place you work,
But I don't imagine issue, I look at the data you have and see the categories that the overall approval stats apply to. I also see the breakout of the stats that we are missing to assign a reasonable chance of approval in the specific Anavex case. I apply my scientific and engineering training to the issue at hand, which you chose to ignore because you want to imagine that your WGT interpretation will apply 1:1 to EMA A2-73 approval in AD.
I can't help you further, but will post my analysis conclusions and change my mind too if presented with a credible counter argument. I haven't seen any...
All drugs and treatments for any indication is included in the 85% figure and therein lies the problem since CNS isn’t one of the buckets in the published EMA stats.
Let’s say in some year there was only eg. 3 CNS treatments that had a recommendation to file a MAA. The possible outcomes could be 0, 33, 66 or 100% for failure or approval. Then add to that it is a new substance eg. A2-73, which is harder to gain approval for than a drug already approved in some other indication.
We simply can’t say that because the overall approval chance of hugely mixed set of applications might be 85% in some year, that it will also be true for specific situation such as A2-73 in AD.
EOM!
Hint! Just some of those factors includes the type of indication category, the type of drug / treatment, orphan or rare indication, is it a new substance not previously approved in at least one other indication etc. Just going with an overall approval rate not differentiated by several factors will be misleading.
Actually your 85% chance comes from misunderstood and misapplied EMA statistics.
some yes,
Like with any tool the user doesn’t understand or have the background and experience using, the result is unlikely to be good or representative of the state of the art.
As the old saying goes, build a system that even a fool could use and only fools will use it.
No substance differences compared to the Jan JPM presentation.
Pathetic!!!
https://www.anavex.com/presentations-posters
Pathetic only up to 2022, everything Anavex since has just stood still!
Except for the share price of course.
https://yhoo.it/493UraV
Probably Anavex did and the guidance was - Great! So based on what you learned design and run a larger confirmatory P3 trial and in due course let us know the results you get.
IHub is extremely bad and has outages all the time. It should not be like that nowadays.
Have you noticed any such useful decisions making information in any other posts not by me?
I second that - outstanding work from ohsay and very righteous too.
The point being that we in accordance with your view really have no need to discuss anything at all here or anywhere, but simply invest sit back and await on some regulatory outcome.
Yah this MB would be such a nice place without me and others not surrendering to the WGT thesis.
Have you ever explained why you are drawn to Anavex or is it perhaps for you an obsession to study why others are?
But as investors we seek input and views to make the best informed decisions we can as to future outcomes.
And you might be doing that more than once each time adopting the same stance.
We just have to disagree what and whom are disconnected from facts and the interpretation of them.
So far the market doesn’t see it your way, but I hope for us all that someday you can claim they should have.
That the video exists is indisputable, however what is appears to portray there is no evidence is the general case or true.
For that we need proof in the form of clear successful clinical trial results, which to date we haven’t seen in any of the 3 indications that A2-73 has been trialed for.
What we have seen is potentially good results in some patients. Those signals, if real, will need to be tested in new well designed and larger trials. If that will happen properly is anyone’s guess just now.
Those ladies, gentlemen and Georgejjl are the indisputable facts!
I do explain the reasoning behind why 85% chance of approval is incorrect and break down why.
I haven’t seen you counter any of that with logic most likely because you can’t or won’t want to undermine your dream conclusion.
If the EMA stats you have been citing were really to be interpreted the way you do, the market would have reacted otherwise than we see.
Fact! Listening to you is a good way of losing money.
Although there are much more fun ways of accomplishing the same.
You have received explanatory replies from me and others, but you haven't taken them onboard.
I only hate when incorrect application of statistics and misunderstood context is promoted as WGT fact.
But 85% chance of EMA approval is ok.
Maybe, definitely maybe.
The real test is will $AVXL ever be an eight dollar stock again?
But you are dumb enough to post how silly you are several times a day on several Social Media.