Doc328 gave Blarcamesine a 5% chance to get approved for Alzheimers

Try shrinking your text to 100% if you have changed the size of text.

For the drugs that got approved with >1 pivotal trial, I wonder if some of those were conditionally approved after a single Ph3 trial with the condition that a confirmatory Ph4 trial be run?

Ah, so the year spent in limbo while Anavex pursued precision medicine was a waste of precious time? Irrelevant huh? Most approved drugs require TWO Ph3 trials? Do you have any stats or evidence to back that up? Maybe checkered drugs like Aducanumab might require two Ph3 trials, however, most the drugs I see getting approved don't.

"Also, this drug makes the elderly very dizzy." #lie #exaggeration

Anavex's biostats guy knows what the FDA requires a lot more than you do.

The second paragraph and its linked article in your post are very significant. Good find. 2-73 reduces amyloid, like the mab drugs, however, unlike the mab drugs, it helps preserve brain volume in the face of an otherwise destructive disease.

As Missling said years ago, dizziness side effect is actually a positive sign for a terminal condition destroying the brain. Why? It is an indicator that the drug is crossing the blood brain barrier and exerting a real effect on the brain. All drugs have side effects. A drug targeting the brain that has zero neurological side effects probably isn't effective. Do the benefits of 2-73 for AD outweigh the side effects ? Hell yeah!

'Doc' has said previously only a 5% or 20% chance of 2-73 getting approved period for AD. So, why do you think he posts so much here for years and devotes so much time to trashing a company and drug he holds in such low regard? The answer is obvious.

Dr. Sabbagh serves on the editorial boards of the Journal of Alzheimer’s Disease and Alzheimer’s and Dementia: Translational Research & Clinical Interventions. He is also the editor-in-chief of Neurology and Therapy. I wonder if Anavex's Alzheimer's Ph2b/3 trial is going to be published in one of those publications?

So, you wouldn't suggest someone invest in this stock, yet, curiously, you are?

Why are you so obsessed w/a stock you despise? Gee, I wonder? Send my regards to your buddie Adam.

Why does someone so very critical of a stock obsessively bash it everyday on ihub for years? Gee, I wonder....... Lol

Didn't he also sell a lot of options recently and take the cash?

"...remember, we are only on year 8 or 9 of a decade average..."

Does that decade to bring a drug to market start from time of discovery of a compound, or from time preclinical trials are done and clinical trials have begun?

Why didn't he wait til the price was much higher than $8.50/share to do whatever he did w/those options? Options mechanics are confusing.

WASHINGTON (Reuters) - Short-selling, the practice of seeking to profit off bets that a stock will fall, is a key focus for U.S. prosecutors, and there will be more activity by the Justice Department in coming months, a top department official said on Wednesday.

The recent rout in shares of U.S. regional banks brought fresh scrutiny by criminal prosecutors and regulators of short sellers, who had previously come under review in the wake of the “meme stock” craze of 2021, Reuters and other media outlets have reported.

But remarks on Wednesday by the chief of the Justice Department fraud section’s market integrity team was the first time that a DOJ official has talked openly about this relatively new area of focus.

Short selling, including via options, is a priority for prosecutors, Avi Perry, the chief of the market integrity team, said at a Practising Law Institute event in New York.

“You’ll see some more activity from us involving short sellers sometime in the next few months,” he said.
[url]https://finance.yahoo.com/news/us-action-short-sellers-likely-190447718.html?guccounter=1&guce_referrer=aHR0cHM6Ly9ndWNlLnlhaG9vLmNvbS8&guce_referrer_sig=AQAAAH5iq_DWYdPf74YwiEbqZuq3KYmJ7WlI37BMk5671BCspxprrVDy96sPcyAzo01VdHbIQhzbqB8IIij8ibJSPgrIZzmWMGFi_4aHORmQdpoP221W_SHx5nGtI38cDFvS7L2M3EqAi3qK4lNIsZQkddJkCupYe55hHE2LTo_xbNOF/url][tag]insert-text-here[/tag]

WASHINGTON (Reuters) - Short-selling, the practice of seeking to profit off bets that a stock will fall, is a key focus for U.S. prosecutors, and there will be more activity by the Justice Department in coming months, a top department official said on Wednesday.

The recent rout in shares of U.S. regional banks brought fresh scrutiny by criminal prosecutors and regulators of short sellers, who had previously come under review in the wake of the “meme stock” craze of 2021, Reuters and other media outlets have reported.

But remarks on Wednesday by the chief of the Justice Department fraud section’s market integrity team was the first time that a DOJ official has talked openly about this relatively new area of focus.

Short selling, including via options, is a priority for prosecutors, Avi Perry, the chief of the market integrity team, said at a Practising Law Institute event in New York.

“You’ll see some more activity from us involving short sellers sometime in the next few months,” he said.
[url]https://finance.yahoo.com/news/us-action-short-sellers-likely-190447718.html?guccounter=1&guce_referrer=aHR0cHM6Ly9ndWNlLnlhaG9vLmNvbS8&guce_referrer_sig=AQAAAH5iq_DWYdPf74YwiEbqZuq3KYmJ7WlI37BMk5671BCspxprrVDy96sPcyAzo01VdHbIQhzbqB8IIij8ibJSPgrIZzmWMGFi_4aHORmQdpoP221W_SHx5nGtI38cDFvS7L2M3EqAi3qK4lNIsZQkddJkCupYe55hHE2LTo_xbNOF/url][tag]insert-text-here[/tag]

Why not offer a 40mg dose? Might be a happy medium between side effects and efficacy. I suppose marketing that dose would require another trial? Maybe add it as another arm to the confirmatory trial?

I remember back in early 2016, Dr. MacFarlane responding to a question by saying that he expected 2-73 to potentially be on the market for treatment of Alzheimers in 2019! Ha, not quite! Lol

I thought the composition of matter expires in 2030. So, 4 years to wrap up another Ph3 for Alzheimers and then 12-16 months after that for the FDA to render a decision. Additional time for manufacturing, distribution, and marketing. So that takes us to 2008-2009 before patients will actually be prescribed 2-73 for Alzheimers and can start taking it. Yet I see no urgency on Anavex's part. Judging by the market's reaction to Daybue's approval, I don't see that Rett approval is gonna do much for the share price, *maybe* a 30% jump? Could get AVXL to $13, but not $100+. Missling is talking like Anavex is on the verge of commercialization. Yah right. I'll believe that when I see it. The logo for the company should be a snail or tortoise. Why are you wasting your time on a company that is so far removed from *possible* Alzheimers commercialization, when you also don't trust the company's management nor the performance of its lead compound?

By the time they'd finish another Ph3, and get 2-73 approved based on that, the patent would be close to expiring. Maybe get a year or two of it being patent protected.

Based on what? The futures aren't green and MA resistance is just overhead.

Have those with the ApoE-4 gene demonstrated in Anavex's trial(s) to respond better, or worse, to 2-73? Or is it just an assumption that they'll respond better?

Oh, no? Which variable(s) do you think will be more influential?

I *think* Piotr seems to imply that precision medicine was not applied to the enrollment of the Ph2b/3 trial, meaning that Anavex enrolled both people with normal sigma-1 receptors and abnormal receptors. Is that correct, or did Anavex enroll just those with the predominant "wild type" (normal) gene for sigma-1 receptors?

Can the Ph3 trials only obtain FDA approval for the pooled results for both the moderate and mild subjects combined? Or, can approval be granted for the mild subgroup alone?

Anyone know how many points moderate Alzheimers patients decline on the ADAS-COG and MMSE scales in 1 year? I wonder if they decline more than mild Alzheimers patients over 1 year?

But the mild subgroup improved from baseline w/negligible side effects. Isn't that good? I invite someone to dispute that.

For example, if someone was put in the 50mg arm but only was titrated up to 30mg max, are their scores included in the 50mg group score because the intent was to treat them eventually at 50mg?

Extend that graph out another 30 weeks and the discrepancy grows larger

50mg S1R wild type! AVXL critics will ignore this group at all costs.

The 50mg sigma-1 receptor gene wild type group. You guys always ignore that. I wonder why that is? Anyway, you have no basis for your assumption. Why would the pooled data be better than the 50mg group, as you implied?

50mg arm is all that matters. You should know that and know its results will be better than the pooled data, especially when just focusing on the S1R wild type group. Precision medicine is the future and the future is now. Anavex leads the way. It worked for cancer and now it will work for CNS diseases too. FDA encourages it and has approved trials that incorporated it Time to pay attention to it.

All that matters is 50mg S1 wild type group. Everybody knows that group has outstanding results. You are looking for things that you can spin to make Anavex look bad. Oh, but you're long AVXL. Please.

As I foresaw, people, with questionable intentions, would judge AVXL without taking into account precision medicine at all. That bumps up efficacy and drug tolerance by 15-20%, or so, which is huge. I'm confidant, at the least, approval will be granted for 50mg dose in people w/normal S1R gene.

Why do you discount Anavex's application of precision medicine and don't you realize that what matters is results for the 50mg subgroup w/sigma-1 receptor wild type gene?

Yes, I'd highly recommend doing that step wise protocol to increase # of patients that can eventually tolerate the higher doses. What about taking 2 or 3 smaller doses/day instead of taking just one big dose released all at once?

Patients that have wild type sigma-1 receptors will respond better to 2-73 and tolerate it better as well. A 40mg dose is also an option and someday maybe an extended release tablet.