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On the positive side, MMRM should give positive results, or at least could very well. Also, what is guaranteed is that: If NDA is submitted, the submission data will have everything that is required by FDA. Of course. Nothing to worry there.
It's just that we (investors) will not know all that is submitted --- and CEO is NOT obligated to reveal everything either (I know SRPT never revealed the actual WB dystrophin numbers for the patients, which were terribly low and came to light only when FDA made their briefing docs public).
At this point, I'll be happy with (1) Reasons for discrepancies in the already given numbers, so we have 100% confidence in whatever numbers are already released, (2) Delta ADCS-ADL numbers.
If I get the above two, I'll buy a boatload more for anything less than $12 (maybe, even $13-15).
You have extremely high expectations. Not going to be happen! I'm willing to bet $10k with anyone (of course, the actual bet is infeasible unfortunately).
CEO will NOT provide any additional data/analysis.
The best (even that is far fetched, imo) that can happen is that he may give acceptable reasons to all the flaws/discrepancies in the current numbers on the slide (e.g., p-values, baseline scores on slide #21, n values for all the analysis).
The above is what I want to hear from Missling.
Exactly. 50mg/30mg data?! Forget about it. I'll be shocked to my life if we were to ever (like in next 2 months!) see the ADCS-ADL data which is like the primary endpoint (and multiple analysts have asked for it). He just won't.
He never released the RSBQ-delta data from AVATAR in spite of being asked multiple times (its really trivial to compute that!).
Do you know how much time this company takes to analyze any data? it is minimum 6 month, check pdd data from tld to partial detail data (he has not published full data even after 2 year). CEO like scientific conf to publish data, embargo is big favorite word for him, so I think next AD data will come during next AAIC, which is June 2023.
Not new -- don't you remember the PDD delay? That was 6-9 months, IIRC!
Mycroft: I have been in this since 2015, and followed the CEO since then. I also like Missling -- for his simplicity, sincerity, scientific expertise, and calm/non-hype demeanor. But, am unable to fathom how he doesn't learn from his mistakes about communication. Anyway, I'm done venting. Good luck to you all.
Can I ask how long you have followed this company?
I’m upset.
You know failing a trial is forgivable — because such is science. You can’t blame a company for a failed trial/drug. That’s what science is about.
But, over and over again, such terrible communication and showmanship by the CEO — is just mind-boggling. Is he really that thick? That he doesn’t understand how badly he has screwed up in the past? Really, I’m astoundingly curious!! Does he not get it? Can’t be hire a $75k/year communicator expert? Is it ego? Stupidly? Deaf? Immunity to non-scientific/market dynamics?
Compare that to SRPT Eg. The CEO PR-Ed failed results within 2-3 weeks of trail completion with EXTREME CLARITY. Stock lost 60%. But the CEO (D Ingram) has extreme credibility. You’ll know if you have followed him.
Monday CC.
Q. Can you please provide the primary-endpoint ADCS-ADL baseline-48Weeks difference compared to placebo?
A. We just got the data a few days ago. We haven’t had the time to compute the ADCS-ADL primary-endpoint. [But, yes, we had the time to compute and analyze the responder data based on an arbitrary threshold … even though it wasn’t even a primary/secondary endpoint.]
===
The above is guaranteed!! And you guys expect the market to show respect to AVXL? Unfortunate.
What about the puts? They love delivering on the puts?
No one is asking for more than top line data!! We want the ACCURATE release of PRIMARY end points. Is that too much? Literally, just 2 numbers (Delta-Cog and Delta-ADL) with correct p-values. Is that too much?
"We literally received it on Wednesday," he said. "We had no chance to calculate more than this topline data and we are obliged for regulatory reasons to inform the public about the data because of its materiality."
He is right on that one, but still not satisfactorily complete. Still many Qs remain (possibly wrong/unexplainable p-values, different values on slide 16 vs 21, delta-ADL value).
If PR headline is ACCURATE, then we have a chance for approval (even if the analysis was only based on patients who had data at 48-weeks).
If there is indeed some half-lie and half-truth kinda situation -- then AVXL itself would brand this trial as POC/P2, and move to doing a P3.
I would give a 50-50 chance to the above two scenarios.
We are unable to find a good explanation for missing delta-ADCS-ADL numbers.
Three possibilities:
1. AVXL lied
2. AVXL is telling half-truth half-lie in the PR wrt ADCS-ADL primary endpoint being met.
3. AVXL really is unprofessional -- and didn't think including ADCS-ADL numbers were important.
Take your pick. I am hoping its #3, but I think it can easily be #2.
Also, I read somewhere that ITT can exclude subjects whose data is MISSING.
I could be wrong though ... .is the definition of ITT very clear-cut?
If the below #2 is correct, then the mean-change should certainly be equal to the subtraction of the two values -- i.e., 2.74 and not 2.26, which contradicts what AVXL is saying.
So?
1. Since they are using the smaller per protocol completers (PP)rather than the expected ITT population I think n should be 161 for placebo and n=301 for treated.
2. The PP cohort is a subset of the whole subset --- the means on 16 are calculated from the entire n=170 and n=338 population while the means on 21 are from the smaller n=161 and n=301 PP cohort
Big question is did the data - either combined, 30 mg or 50 mg hit the endpoint using the ITT or mITT cohorts
Doc: How does the new deck answer any Qs? I have the following:
1. What is the n used for ADAS-cog (and CDR-SB) p-value calculation?
2. Why the baseline numbers on slide 16 and 21 do not match?
Note that if slide #21 the mean-change is not the same as subtraction of means --- then baseline mean score must include 'all" the patients and the treatment mean score includes only the patients with 48-week score. IN WHICH CASE, the Q2 above stands (i.e., the baselines numbers on 16 and 21 should match).
IRRESPECTIVE, the good news is that AVXL is standing by the key numbers of relevance:
1. ADAS-Cog: Delta benefit of 1.85 with p - 0.033
2. CDR-SB: Delta benefit of 0.41 with p = 0.04
I'm not sure how they are getting the p values even if I agree with everything else they say!
Why is top line a fail? Because if pooling or errors?
What a disaster. $11 on the seemingly greatest news!
I posted the link. Here it is again:
https://www.dropbox.com/s/a9sghikrwp0sh1s/CTAD%20ANAVEX-2022.pdf?dl=0
Slides Link (my dropbox)
https://www.dropbox.com/s/a9sghikrwp0sh1s/CTAD%20ANAVEX-2022.pdf?dl=0
I'll remove the above in a few hours (Don't want AVXL to come after me for distributing something that they have removed :)).
I have the slides. Let me know your email address or how to send it.
IR REPLY for the 2.26 vs 2.74 error.
IR says it's not an error. # of patients were different, so the mean change is not the subtraction of the values.
I guess that makes sense. That's why the subtraction is almost accurate for placebo but not for the drug. What do you guys think?
So -- if patients dropout (drug withdrawn) of the treatment group -- they don't need to be included in the analysis?
FU of highest order from AVXL.
Worse than those for previous trials.
At this point, I’m unclear if the truth — thought it’s likely that the PR statements are true. But I can’t be very certain.
However, if the PR is really true — then this deserves to be $30+ today ….
No, dose-results will not happen today.
Though -- I did write back to Clint/IR that they should also fix the omission of the ADCS-ADL primary endpoint delta compared to placebo. Who knows -- if they issue a new PR -- they may fix that too. :)
For me, fixing the errors and adding the delta-ADCS-ADL will be more than enough!
Will he be able to separate the 30 mg and 50 mg results quickly?
AVXL will/should fix errors before UN-HALTING the stock. That is what I believe will happen, since IR is aware of the errors since 4am ET. Let's see.
They have already removed the slides. Looks like they are in action.
(Can't sleep tonight).
Regarding the values in the brackets: Slide #16 may be giving Standard Deviation, while #21 Standard Error (which is SD/sqrt(n)).
Wrote to IR last night about the main errors, and just got a response (4am EST) that the team will review.
I care about my investment. The Q I need to answer is --- if stock goes to $25 tomorrow, should I sell or hold for $100 in a few weeks/months? The answer may be easy for you, but its not for me (I do regret not selling for $30).
If there are these discrepancies in data results and/or is AVXL has really screwed up somewhere (its possible) --- then the stock may remain stuck in 10s or 20s, at most.
The seemingly good results -- had they been released very professionally and accurately (including disclosing dose-level as well as delta-ADL scores) -- I would have strongly believed that the stock will see $100+ soon. Unfortunately, with these goof-ups, I don't feel that it will see $30+ for quite some time --- unless AVXL comes out very clean very soon.
What is more reliable — PR or slides?
I’d guess the PR, since if PR has errors and not corrected asap — AVXL can get into serious legal troubles. I don’t think AVXL is directly responsible for conference slides presented by its PI.
Yes, I heard that. Sounds very strange to me — that AVXL is getting data after 5-6 months?! And they booked the presentation 45 days ago?
Even if that’s the case — how is ADL responder analysis any simpler than the difference in mean values (the real endpoint)?
I just want AVXL to fix the slide #21 numbers asap, and provide the ADL score-change numbers. ASAP.
Thanks a lot!
Where did you find these numbers of patients who dropped out (3 in treatment and 2 in placebo)? I couldn’t find it ..
Yes, I’d be happier to have waited more for a more complete and professional release/numbers! Absolutely.
Thanks, Doc, for your points.
One more: What do you think if the discrepancy between baseline numbers on slide #16 vs 21? (For Cog scores).
The footnote of slide 16 says : “5 patients not randomized”. Could the discrepancy be due to this? Why would 5 patients not be randomized?
Because AVXL is clumsy!
Eventually, it will likely be a trivial error. Likely, yes.
But, market will not react kindly to it. Likes if AF et al.
AND, it’s unacceptable!
It will open $15-20, bur close $10-13.,
If it dips below $10, I’ll buy more.
If it goes above $20, I’ll sell 25% of my holdings.
After 6 months, AVXL couldn’t present data for each dosage arm!
They could have shown dose-dependent response … which would have been a killer!
Either they didn’t get dose-dependent response (really?) or they are just clueless (in what/his to present data)!
No, Im not selling. But, I would love to have answers if possible.
I don't want to be blindfolded for sure -- like most of you.
Frol: I would love to believe you. But, 6 months is not enough to get numerical data and do subtraction properly? If this was July/August, I'd believe you. This is December. And, they haven't had time to determine ADCS-ADL change?! And, what about the arithmetic errors?!! Unbelievable.
The problem is --- that these omissions and errors will kill the market tomorrow .. or at the very least cast a serious doubt.
Do you imagine NYT/WSJ running a piece of this type of data release? Absolutely not -- too many arithmetic errors/omissions to risk for an NYT journalist.
Do you have a better explanation?
Questions/Inaccuracies to be wary of [What I say doesn't matter, market is going to catch up on it].
Please answer here constructively, if you have answers.
1. ADCS-ADL treatment change not report. Why not? Why report just the -3.5 threshold result?
2. Why are the baseline values for ADAS-Cog different on two difference slides #16 and #21.
3. What the footnote on #16 mean: "Full analysis sets. Includes 5 patients not randomized"?
4. Note the arithmetic errors (30.36 - 27.62 <> 2.26) on Slide #21.
This is where AVXL has either screwed up in PR/Slides/Communication, or is hiding something.