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It MUST exist and in CM’s hands. No reasonable explanation can suggest otherwise.
Then, why the delay? CM is trying to figure out how ti spin the failure —- as he did for AVATAR, PDD, P2b/3. EACH ONE OF THEM!!
And, his new hires haven’t taught him anything about how to PR results. What a shame.
Thanks. Btw, is LSM being different than “delta in mean” also a controversial/questionable strategy of avxl? Or is LSM considered sane/interchangeable with “delta of means?
Just read the first sentence of what you quoted.
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The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025.
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Also, this point isn’t very important/worth debating. The critical point is ORs vs LSMs — which one of them is the truth, and are the calculations accurate.
Ignorance is bliss. Go for it.
With such fundamentally flawed understanding of trials data — how do you manage to opine ad nauseam about the drug’s prospects?
Most trails have only one primary endpoint (i.e, what is measured and what statistic/measure is used to compare; the latter is mostly the "delta from baseline to trails-end). In P2b/P3 case, CM never disclosed how the two primary co-endpoints Cog and ADL endpoints will be compared, but at CTAD came up with ORs as the way to do it (which he later changed to LSMs recently).
P2b/P3 was unusual -- in that, it had two primary endpoints. That's actually putting unnecessary burden on yourself -- since you need to pass both with p < 0.05 -- so I fail to see the point of having two primary endpoints.
However, it seems statistically reasonable (but I have never seen before -- so, not sure if FDA will agree) to consider the trail a success -- if any one of the two co-primary endpoints passes with p < 0.025. This is what AVXL did recently with delta/LSMs as the comparison measure.
Point: Irrespective of SAPs, the primary endpoint was known. How it should be compared is also pre-specified (and, in almost all cases, is disclosed to the public). That is what defines true success in a pivotal trial. Anything else -- is ad hoc analysis and puts trial success into a question mark (but doesn't necessarily mean an NDA rejection).
Can someone post the links to the videos?
I don’t blame CM for missing deadlines. There can be many (valid) reasons — some out of his control.
But I can’t forgive him for
1. Blatantly lying (or obfuscating the truth) about something as fundamental as endpoint results. That’s just a man of low character.
2. Even worse (perhaps related to #1) is PR-ing very confusing/inaccurate/incomplete trial results OVER AND OVER AGAIN. How did he manage a PhD??!
The board is full of blind-folded WGTs (eg they still believe that P2a/3 endpoints were met, even after the flip-flop by CM. Same for Avatar).
Attacking and trashing of any negative posts is what they do. How else can they remain comfortable in their cocoon?
OTOH, you shouldn’t be swayed by their attacks — since they are thoughtless and meaningless. You are also just venting your frustration. What else purpose does criticism serve — since we have zero chance of effectuating any changes (eg getting CM fired).
Bottom line: Enjoy your freedom of speech. Let others enjoy theirs (including the ones with minimal insights and thoughtfulness).
No corruption at FDA. Yes, the lower-rank employees are not top-notch and not the most-brilliant scientists (FDA can’t hire the most brilliant of people) —- which creates a small bit of incompetency and sometimes immaturity/ego issues. (I know of specific examples of scientific errors/confusions made by them). Other than that, I also accept that FDA can make wrong judgement calls too.
Else, nothing wrong at FDA. I have very high respect for FDA. I have followed Sarepta’s drug approvals/rejections very very closely (even interacted directly with FDA very top officials — who have been extremely prompt and responsive and receptive/open to my pointed scientific issues in their public drug reviews).
First, we need to see EXCELLENCE results. Proclaiming confidence/success before that especially after AVATAR’s failure is silly.
Did you miss the direct Q in my post? You seem to have written something completely irrelevant to the Q.
The delay in EXCELLENCE results is certainly freaking me out --- it points to "deja vu" (PDD, Avatar, CTAD 22, .. )
As an example, look at Sarepta:
Mid-September: EMBARK Trial completed.
End-October: Results PR-ed (of a FAILED trial AFTER meetings with FDA leadership).
Mid-December: Supplement submitted to FDA for label expansion and full approval.
That’s how well-managed and truthful companies work.
Is there another company that takes 6 months post-completion to PR trial results?
My confidence that EXCELLENCE has failed is very high right now. There is absolutely no other reasonable explanation to such delay. History confirms it — but AVXL has “failed” (almost) all trials so difficult to draw a conclusion from history.
You guys are delusional. Buyout at any point would never be more than 3x the market price.
My best/dream case scenarios would be: Rett approval plus EU AD approval over next 1-2 years.
IF that happens (10-20% probability, I’d say), then we may see $100-150.
FDA AD approval of any kind can only happen after another trial — which by CM’s pace I’d say is another 5-7 years if at all.
Minimal chance of any other indication approval coming into play before 5 years.
No company hides trial endpoint data — for peer review. Journal publications matter to professors — not companies (certainly not AD drug companies, who are shooting for billions of dollars in revenue and 10s-100s of millions through stock sale).
But, yes, I agree that CHMP/EMA has seen data that AVXL has presented to them (not sure “full”) and EMA has considered the application to be “eligible”.
However, I’m unclear (provide me a solid link, if you are clear) —- what kind of data is sufficient for eligibility. My thinking is — a “valid” P3 trial (without much assessment' of the data) is sufficient. Non-trivial data assessment is only during the review.
However, it’s also obvious to me (and EMA, IMO) that probability of approval is NON-ZERO —- so that is sufficient for eligibility. I don’t think there is anything more to eligibility.
I also believe that probability of FDA approval is zero based on current trials (simply because the current data is insufficient, and AVXL hasn’t said much for 1.5 years now).
My assessment/opinions only.
When did he say “surprise”? I know he said it for the biomarker data — did he say it another time too?
More precise quote was:
“We are on track to release/share the data when we have it”.
Most meaningless sentence ever spoken by a CEO, I reckon.
"Is it simply altruism at its finest or perhaps an agenda at play here"
I'm sure it's neither. My guess is that people love to talk/write/discuss. So, it's semi-entertainment, and I'm sure it's also a bit of imparting and gaining knowledge to/from others.
What makes you think they are convinced of all that?
Being convinced of something that will affect 100s of millions requires very very serious scrutiny—that’s what takes 6-9 months.
That’s what is called a pipe dream.
This analysis is not a basis of approval — so doesn’t need to be pre-specified. However, this analysis may support the reasoning behind the mechanism of action — and may inform their future trials and/or indications to pursue. In that context, it may be useful. It may also form supportive evidence for approval, if the primary evidence is reasonably solid.
"They are hiding something"
So, you think they are not hiding anything at all?
Can you be more specific? Which inference? And what inference are you deriving?
Please pick a sentence you disagree with — apart from my opinion of FDA approval, rest are just facts.
AD trial was completed July 2022. After 1.5 years what data do we have:
1. 12.22. Botched/incomplete data. Claiming full success based on likely-changed-at-last-minute measures (OR) — that too full of many errors.
2. 2H23: Changed the measures to LMS. Excluded one endpoint (ADL). Some grossly incomplete data on a couple of biomarkers.
NOTHING ELSE! That can only mean one thing — the missing pieces of data are negative. 100%.
Of course — the blinded ones consider the trial to be a success — and even hoping for FDA approval! FDA will never approve based on current trials (even though I haven’t seen all the data). EU may.
Yes, but most are blindfolded WGTs or worse pumpers.
I’m afraid that today’s news seems to be laying the groundwork of a failed result if EXCELLENCE —- so CM can do some obfuscated biomarker analysis instead of the originally planned endpoints.
6 months since trial completion and no results!! That doesn’t sound like a successful trial… by any stretch.
Today’s news seems like a semi game-change.
Till today, it was unclear (to the sensible ones) if AVXL had the goods to file a drug approval application.
Now, it’s a 100% certainty that AVXL will file an application. And, the probability of approval is certainly non-zero (how low/high is a matter of debate).
Thus, I expect the stock to continue to be strong barring any bad news. This could trade in $8-15 range over the next few months (but Rett’s news can change that in unpredictable ways).
So, CM is planning to make a submission without having (yet) disclosed to public the dosage-level efficacy data.
What does it mean?
I’m sure the dosage-level data has questionable efficacy. How can he expect EMA to approve in that case?
The application hasn’t yet been submitted. Read the table more carefully. We are still in pre-submission phase.
Yes, no one is perfect.
But I can name many CEOs who have not lied (as CM clearly has wrt to the endpoints of recent two trials).
Can you name one company/CEO — who takes 6+ months to report trial results (that too partial)?
Irrespective — I agree that successful companies/CEOs, especially in biotech, go through many failures/bumps. Anavex can certainly succeed over time—but very tough to sit through sheer incompetence/borderline-fraudulent tactics of CM.
Of course, it’s possible but unlikely. AVXL History says otherwise. Plus, no reason for 6-month delay. Even if you ignore that, that are two issues:
1. Why did avxl go down to $5?
2. Market certainly can’t be positive about excellence (ie there is no leak). At best, it could be neutral.
At $10-11, I’ll sell 25-50% of my position. CEO’s ineptness is a permanent hurdle with this company.
At least I got the right feeling.. days ago.
Surprised and impressed by the action. Doesn’t seem fake.
However, we are still only $7, compared to $12-15 before AD results.
Only for the non-WGT crowd:
Why is AVXL moving so strong? Certainly, the EMA approval is not being looked upon as a non-trivial probability by the ones sensible?! Rett’s trial results are likely being cherry-picked. So, what is the market thinking?
That’s a silly point. No company is going to use statistics like that to communicate that it has 80% chance.
You read George’s posts? Why?
Why do you care about the posters here? They gave zero ability to move the stock anyway.
Best to just focus on the company.