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AF is 100% correct. AVXL has certainly made-up endpoints and/or outcome measures.
AUC (back and forth) is too obvious a proof of above.
I think you should put me on iggy — as I have. We are on completely different levels.
Get this.
CM is still waiting (after 12 months of trial completion) — for a few additional months — to get “preliminary” (!) efficacy data, to THEN start conversation with the FDA.
Of course, 8 months ago — he also proclaimed “All primary endpoints met with statistical significance”.
What do you make of it? Likely, sheer incompetence—-or worse, trying to make a fool of the market. Time will tell.
They already covered — and made a killing. How are your long buddies doing? Still waiting to recover the losses? Awww…
In short, the market is excited about:
(i) AD biomarker data which CM alluded to in April -- but is now promising to PR sometime this year. WHY THE 6-MONTH DELAY (even after having seen the data somewhat)?
(ii) Possibility that the extension study may be the confirmation study -- if the biomarker data can be used for AA. I find this extremely unlikely -- but doesn't matter, as long as AVXL gets the AA based on biomarker data.
(iii) Pending EXCELLENCE topline data.
However, the above don't mitigate the main issues with AVXL: (i) Why the delays? To me they point do data engineering. (ii) Difficult to ignore the possibility that CM will continue to manufacture endpoints/outcome measures, lie (or say half-truths), and delay and delay and delay ..
Nevertheless, a very strong/perfect day today. Strong volume (but not explosive, which is great), close at the HOD, and most importantly, delayed reaction to the CC (plus, after a shakedown). So, very strong technically.
It's always easy to imagine heavenly outcomes --- but there needs to be a BASIS (else, you are just dreaming like winning a lottery ticket). The way AVXL and CM have operated over the last few years --- I don't see any basis to hope for an UNAMBIGUOUS POSITIVE trial result, after 1.5 years of trial completion (have you ever heard of this much delay in pivotal TLR??!!).
If an approval happens in 1-2 years, all sins may be forgiven.
But, it seems like a remote possibility based on the history of how CM operates.
It is not meaningful or wise to imagine things.
That too — if it does happen before TG. 2 years wasted in my eyes — for whatever reason.
In comparison — SRPT’s trial will end September 2023, and the data (full!) will be released by Thanksgiving.
In contrast, it look AVXL 6 months to get the data, 2 weeks to present endpoints’ data (which it has stood by), and further 8+ months to make it “complete”.
No one believes CM. I don’t.
After one year of completion, AVXL says it will release PRELIMINARY (!) efficacy data in the second half!
Wow. Talk about a snail’s pace.
No one believes what CM says about trial initiation. The Parkinson’s trial is in PLANNING stages??! That means it will start if at all earliest in 2024 end. Guaranteed.
The endpoints of excellence is spelt out clearly — what about the outcome measures? Would it be odds-ratio? What threshold? Of course, it will be eventually made up.
The street is completely tuned off. Only Sumit Roy has the stupidity required to say “Congratulations on all the progress”!!!
Do you even understand what I am trying to say?
Next PR from AVXL proclaiming “All primary endpoints met with statistical significance” — even if actually true — will be met with extreme suspicion and would certainly cause the stock to crash (at least for a few days — till the PR’s every detail is completely verified).
AVXL has zero credibility—and rightly so. I have no idea what CM was thinking in Dec 2022!
Subgroup analysis never works for (full) approval, unless it’s “Pre-specified”.
Pre-specified could mean many things (eg if the randomization was stratified based on that criteria).
Accelerated approval is a slightly different matter — for multiple reasons.
1. AVXL thinks it has approval (AA) worthy biomarker data.
2. Data hasn’t been released,
3. It has been one year since trial completion.
Wow. What to make out of the above facts? My theories on potential facts that may explain the above:
1. AVXL has good biomarker data — but far from being approval worthy. So, it’s just spinning it (eg finding the right threshold can take time).
2. AVXL is extremely slow and clueless — doesn’t understand the implications of slowness. So, even though it has/may have great data, it’s taking its sweet time.
3. We are being impatient; it indeed takes 1-2 years to get the biomarker data out.
Take your pick.
Very funny (preposterous).
CM releases “a home run” PR in 12/22, and then proves that he basically lied through his teeth —- by incredible silence and zero-progress for 7+ months!
People who believe in 12/22 results are just fooling themselves.
No, Sarepta’s market cap remained in $1-2B range for 1-2 years even after two approvals of drugs with total 23% of market addressed.
The jump to $5-10B range was due to the blockbuster gene therapy potential unveiled in June 2018.
Who still believes the below headline from December 2022?! If you do ……! Seriously — never too late. Will help you think clearer.
7 months ahead — no meetings with FDA, zero progress/updates, zero clarification of the data inaccuracies and miscalculations. And, most convincingly, plans for full-approval replaced by AA based on NEW biomarker data (yet to see the light of the day).
Still believe the below? Sure — enjoy the bliss!
ANAVEX®2-73 (BLARCAMESINE) PHASE 2B/3 STUDY MET PRIMARY AND KEY SECONDARY ENDPOINTS,
SHOWING STATISTICALLY SIGNIFICANT REDUCTION OF CLINICAL DECLINE IN GLOBAL CLINICAL STUDY OF PATIENTS WITH EARLY ALZHEIMER’S DISEASE
https://www.anavex.com/post/anavex-2-73-blarcamesine-phase-2b-3-study-met-primary-and-key-secondary-endpoints
Woah! Those are big dreams.
Is this AVXL’s novel way of changing endpoints after the trial end?!
No, the reality is --- some people bought in a RUSH, and then different people sold because they got a chance and/or they didn't believe it will continue to go up.
Result: The $10 sellers are gone/reduced. So, the stock now has a chance to go up even without much volume --- but, there needs to be a fundamental reason to do so (Excellence results and AD biomarker data are reason enough, imo).
In my eyes, today was a very positive/good (not great, of course) day. It shows that there IS interest in this stock.
First no-news explosion days always fail — but there will be more and they will find much less resistance going up. I’m sure they’ll come soon again.
Pure stock manipulation. Pump and dump. As I have said before (to counter the cabalists): the stock is being PROPPED UP artificially up by XXXX manipulators.
Perhaps. But, that doesn't mean the stock won't crash to 8.
It's difficult/impossible to surmise what is the objective of the people who bought at 9.8-10.2. E.g, what is their stop-loss if any and their target timeline.
IMO -- technical trading should be fundamentally played short-term.
If you want to play long-term, you gotta largely stick to fundamentals.
More importantly, SUSTAINABILITY of this move will depend on the fundamentals — in this case it’s tricky to call, but likely positive … so I predict/hop that this will trigger a move to $12-13.
Nothing is up. Stocks like this explode suddenly for no reason (fundamentally — because someone buys a big chunk).
Here I see there was an option block bought at 12:47. Likely that’s the trigger.
My favorite is SRPT. If you follow it — you’ll know. DI PR’ed every material event/meeting even if negative immediately—- and when he didn’t want to (eg FDA discussions after rejection of 2nd drug), he said so clearly that he won’t talk about these discussions until they reach a conclusion (famously quoting — I don’t want to die a thousand deaths).
Compared to Douglas Ingram — CM is a true quintessential coward. My very strong opinion.
Objectivity takes a lot of sensibility and prudence.
AVXL has nothing to discuss with FDA. CM himself has reiterated this MANY times in CCs —- that FDA meeting is useful only when we have data. And there is no noteworthy/approval-worthy data yet.
AVXL should ideally be doing both — journal articles (for trial results) and NDAs.
If they can do only one without delaying the other, then of course NDAs.
They could be going to the moon, for all we know. Yes.
BUT — there is not a single evidence (Ie an unambiguous statement) of any meeting with FDA ever! The max I have heard from AVXl is “guidance/communication from FDA” — and that too only in the last PR about EXCELLENCE endpoints, I think.
That’s why — it’s inconceivable for me to believe that FDA meetings are happening — esp when Cm has nothing to talk about (no data results — 12/22 data doesn’t count)
My timeline. Yes, pessimistic but unfortunately also realistic. Look at the past history if you doubt the below. Hiring of a statistician may improve quality of PRs, but not the time to do things.
Rhett data PR’ed: Nov-Dec, 23.
“Meetings with FDA” : March-May 24.
NDA filing: Q4 2024.
For AD AA:
Biomarker Data: Q4 23
FDA meetings: Q1-Q3 24
NDA : Q4 24 - Q2 25.
ZERO CHANCE of an NDA being filed in 2023.
Yes, FDA reads/refers articles (by third-parties) in their review.
But, they rarely depend upon or give value to sponsor's articles -- in reviewing their NDA.
In this context --- AVXL publishing any articles is of some value -- but not much. The value of publishing journal articles is: (i) Lends credibility to their research and results (but only to investors, not FDA), (ii) In case of AVXL that doesn't know how to PR clear results, articles is the only way -- for us to see the complete results, if at all.
Let’s try one.
Did AVXL go back-and-forth on RSBQ-AUC?
If I believe what I say, how does that guarantee that AVXL isn’t going up from here?! Is it that simple?
In fact, I believe AVXL is going up till the day the biomarker results come up (on and after that day — I can’t say). Irrespective, in spite of CM’s lies, AVXL can still hit a home run. Likely more delayed and less probable now than my imagination before 12/22.
Worth repeating.
1. AD P3 with SPA and US-based.
2. No more endpoint change. (Do we have 100% certainty on what the EXCELLENCE endpoints are? Well, what
CM says doesn’t really count …)
EXACTLY my list of issues/concerns with the company’s behavior.
My conclusion is;
1. CM is a coward — doesn’t have the courage to admit trial failures. So makes up endpoint after the results (has certainly happened twice, in all likelihood).
Biggest evidences are — his switches on AUC (!), and plan to go AA after having met all primary endpoints!
2. In addition, CM/company is extremely slow (likely as a result of being CHEAP, and/or taking time to “cook” the endpoints).
3. Small biotechs do indulge in a bit of above. Eg, even SRPT didn’t disclose the WB dys expression numbers in 2015-2016 (not that they really had to, but they seemed very material to many). They came out in FDA’s briefing docs — and were a shocker that the avg expression was only 0.9%. However, they didn’t do any of the lying, or cooking-up of endpoints, etc.
Definition of efficacy is different on the AA route. (Per law).
I had explained this earlier.
If AVXL gets AA based on some biomarker data in P2b/P3:
First assumption is that FDA will only give AA without any subgroup analysis, except for the dosage grouping. This assumption is extremely likely to be true.
With that assumption — a confirmation trial would need to show clinical benefit for the same population as in the P2b/P3 (else it wouldn’t be confirming the basis of AA).
That’s why.
Future trials could mean any of the indications.
For AD. If AA, then the confirmatory trial will have similar inclusion/exclusion criteria as the P2b/P3. If not AA, then CM could (based on biomarker data) try something more selective for the next P3 trial.
If you think I was being too ambitious — well, it could certainly take much more (7-10 years) if there are more missteps/failures.
5 years was assuming — no failures/missteps but AVXL’s traditional pace.