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Oh geez, so what's your issue w/slide 17? The wt group was 8% higher. And that's bad?
So why didn't Anavex present the @#$% CDR-COA score? It was the primary endpoint! If it was good, wouldn't they have mentioned it in the presentation and at least included it in the slide deck?
I googled the 2 tests and didn't come up with bupkiss. I didn't find any overlap or "underlap" between the components of both tests. Care to explain where that exists?
CDR-COA was the primary endpoint and that was not given at CTAD. Why? Anavex doesn't even report the results for the main thing they tested for. How does that make sense? Simple reaction time data analysis was delayed or there was some sort of problem testing for it or its results were poor, otherwise it would have been reported, along with CDR-COA, of which it is a component. I wish Anavex would have given some explanation for why the primary endpoint wasn't given.
Doc, You should contact Dag Aarsland professionally and inquire about the trial. He could give more clarification.
Outcomes like SRT and Tracking (motor control) may not have been touched on b/c this is an AD conference and is more focused solely on cognitive function.
How might the covid pandemic have affected the trial and its outcomes? I don't think it was a positive influence.
So why didn't Anavex at least include the full data in the slide deck? With the lesser relevant data, coulda listed it on one slide without going into full detail, or even mentioned it in the CTAD lecture. Woulda shut up a lot of naysayers. So why not do that?
Would shorting BIIB tomorrow be a good idea? Hmm...
So the tests from the battery that were not mentioned aren't related to Alzheimers? Numeric working memory was listed as a key cognitive domain, but no data was given for it. Why? Same w/word and picture recognition. What gives? Maybe there wasn't time to get into the entire cdr battery but the slide deck could have included that data. It would have really helped legitimize the trial and presentation.
But why no cdr-coa score and p value? Why not list results from every test that makes up the full battery of the cdr?
On slide 16, 5 cognitive domains were listed from the cdr battery which are most pertinent to assessing/diagnosing MCI-AD. The first four of them seem to have been addressed in this presentation (word and pic recognition were bundled into calculation of the Quality of Episodic Memory score). Was numeric working memory addressed? Slide 20 includes Digit Vigilance Reaction Time. Is that part of numeric working memory?
Overall, I think results were impressive, especially considering the trial was affected by a pandemic and PDD was never even on Anavex's agenda as a target indication. They just explored it b/c the Michael J. Fox Foundation wanted them to and would help foot the bill. The presentation had to be brief, so anavex just focused on the most pertinent data from this Parkinson's trial related to MCI-Alzheimer's. Remember, the trial wasn't even an Alzheimer's trial and the patients didn't even have Alzheimer's. CTAD is an Alzheimer's conference. Data presented included both doses (the 30mg cohort is always a drag) and did not select for subjects w/WT Sigmar 1 and COMT genes. Precision medicine is the cornerstone of Anavex's strategy, and that wasn't even applied! AVXL's critics *conveniently* fail to mention all of the above.
Chart still bullish despite the pre-planned bear raid.
She probably gets paid to trash stocks. That's how the game is played in biotech surrounding news releases. She's like Fuerstein, just cheaper. She projected when she tweeted, "Pure filth."
2-73 isn't meant to be a cure. let's keep it real. its goal is to beat placebo and slow decline w/out intolerable side effects, which would be very impressive. btw, every drug has potential side effects, even an aspirin.
Called it! Lol
Harry Johns is the president and CEO of the Alzheimer's Association, not the fda
How did Anavex score a ctad invite so late?
another great day for avxl. outpacing the markets.
pdd wasnt anavex's idea. mjff wanted to do a pdd trial. they'd partially fund it. so anavex was like, 'ok, if mjff wants to do it and fund it, sure, what the hell'. it wasnt ever a primary target or on anavex's radar screen
Trial ended officially when, 9/30? That's what clinicaltrials.gov says, updated 9/2. So then gotta allow couple mos for analysis.
So basically, 273 has to prove itself a cure to gain approval. Oh, is that all Lol? BTW, what was donepezil's p value for its Ph2, and the Ph2 p values for the other 3 drugs approved to treat alzheimers? 0.0001?
I'm still surprised Shake It Up foundation didn't wait couple months for the PDD Ph2 results before committing to fund a large Parkinson's trial. Surely they knew about the PDD trial and its primary and secondary outcome measures?
Will this new trial be Ph3?
Does anyone know exactly when the Ph2 PDD trial officially ended? I've read as late as 7/31. NTRP took 2 mos to report results after their last Ph2 trial ended, and they didn't even have to wait for 3rd party precision medicine analysis.
If the high conc group had a normal incidence of Apoe4, do you think that group probably would have scored better?
So, 2-73 was most effective in subjects w/Apoe4, or in those lacking Apoe4?
High concentration group had higher frequency of Apoe4, so that may be why Apoe4 had the low p value, no?
NBC foreign correspondent Richard Engel has a 3 yo son w/Rett. insert-text-here
Anavex isn't trying to treat everybody w/rett, alz, pdd, etc. They are just trying to treat subsets (people meeting certain conditions and biomarkers, like dosage, mild stage of illness, genetic profile, gut bacteria, etc). Raw data is meaningless.