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Maybe my illustration made you see the folly of all the wheel spinning.
What then happens say at 20 weeks, 28 weeks, 6 months, a year? No more juice in the A2-73 arm, but patients on placebo just continues to improve?
I guess Anavex would be better off with the next trial being larger and only 4 weeks duration with 1:1 drug / placebo arms.
How come someone is posting about others posting about others and do so...on a weekend!!?? and so it goes on...
How does that make A2-73 any better than placebo?
Provided that Anavex actually files an NDA with the FDA for Rett, yes.
Indeed!
Well we can better understand how good the P2b/3 results really were first if the MAA is filed and validated and then ultimately if approval from EMA occurs.
Either way the placebo and drug arm response profile didn’t separate and the trial failed.
You don’t think there was any disappointment and frustration in the Anavex team and among board members during the time when it was known the EXCELLENCE trial failed and the long procrastination before publishing the trial update (not TLR) PR?
Do you know why the absolute change in the treatment arm appear larger in the A2-73 vs. trofinetide?
I did and your "better" alternative wording still leaves the same issue, which is that it is the difference between placebo and drug response that matters.
Just as a reminder here is what you were discussing,
You may want also read Doc328’s post on the subject.
That was quick.
I know you need time to make your posts as ‘clever’ as you can manage.
Projecting that to others is a mistake, which I’m sure catdaddy will join you in.
It is understandable that neither of you ever post anything about Anavex or of substance.
I don’t think the family will miss the few minutes I use posting here.
I’ll be here keeping an eye on you and few others as we wait to get $AVXL up to $6,000 as forecast by Mayo. What could possibly go wrong?
I’ll go with dotcom’s sentiment and can afford to just let my much smaller holding ride. Who knows perhaps there will be a surprise however small the chances.
Excellent and well done!
Then by all means feel free to pursue your hobby of only posting about other posters at your leisure.
At what price would you sell $AVXL? That is of course if you own any $AVXL to sell.
On the other hand if you are still on the $AVXL millionaires list, I can understand why you don’t need to post about $AVXL and just enjoy berating posters.
Hang on a second, I was assured that $AVXL would never get as low as $8 again. Can we up the bar here a bit please.
Yeah pretty much on point.
Here is what you said.
Lol! you need an article full of errors to understand the P2b/3 AD trial results much better.
Effects size proving stronger? A2-73 didn’t beat placebo, so your statement is nonsense.
Still in regulatory terms nonsense even if deeper forensic analysis indicates what Dr. Kaufman expects.
The only way to potentially show a large effect size would be another well designed larger trial.
inclusive -> Inconclusive, but at present a topline fail.
Worst case for Rett is running another trial and again failing - just to be pedantic. Who knows it could happen just as it could be a success. Things a bit inclusive at this point.
Biotech investing is not for everyone.
Can’t keep the same patients for a new trial.
Missling is very good a surprising the market, but it seems at least some staunch WGT investors still believe an even bigger surprise is in store.
Looks like the dry powder ended up damp (again) for the 🤡 here.
The longer we wait the more perfect it will be!
Anavex have not met with the FDA yet about Rett or the P2b/3 trial, according to what I heard today.
The MAA filing is an ongoing dialog with EMA and Missling can't and won't put a time to when that dialog may result in an MAA filing. I guess its less easy than expected to convince EMA that the data is all there to slip through the CHMP Day-1 validation.
But yeah, there is of course an 85% chance of approval. Nonetheless, I still need to see that Anavex, as Missling said they would, PR the MAA filing. Then I can update my chances of approval maybe next Feb'ish.
Oops! some more dry powder gone damp.
New larger Rett P3 trial almost certainly required.
MAA filing likely closer to Christmas than Q1.
Lol! you persist like a little terrier in maintaining an incorrect argument.
To the extend your WGT investment thesis turns out correct you are not affected.
This is the relevant process: https://learning.eupati.eu/mod/book/tool/print/index.php?id=893&chapterid=822
Anavex appears to still be somewhere in the first row of the table. CHMP rapporteur’s and co-rapporteur’s teams only get involved once the MAA is filed.
Everything you list is related to development, which is all done for the P2b/3 AD trial. The CHMP Rapporteurs are only assigned when the MAA is filed!
You need to comprehend what you are reading and posting, not just post something in aid of trying to not agree with what I say.