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Which “how” part is unclear to you?
Assuming, ORs are the endpoints and the numbers in the CTAD presentation are accurate.
What is missing then? You can’t expect AVXL to share the calculations for p-values.
Per my modeling, AVXL would hit $150,000 per share in 1 year. And, I’m being very conservative here.
Unimaginable imagination!
Sheer incompetence and unprofessionalism.
OTOH, how does it matter? I mean -- the communication being screwed up -- doesn't fundamentally change anything. If these results were PR-ed a year ago, what would it have changed fundamentally? Nothing.
However, more important Q is --- when is CM planning to start the P3 for PDD? Maybe, he is being conservative .. and wants to get more confident about a trial's success before pumping $50-100m into a trial/indication.
That’s cluelessness.
Or maybe, stock manipulation IS the reason why the stock is at $8.5 rather than $5. Manipulation by pumpers.
Biggest positive of todays PR:
They seem to have suddenly learned how to present data! First PR with a table!
Good things to come, I hope.
Is AVXL just a disappointment (due to CEO’s incompetence in some aspects) or is it a “scam”? The latter possibility can’t be completely dismissed — because the CEO has certainly lied a few times (eg regarding RSBQ-AUC in AVATAR. Perhaps, similarly about P2b/3!).
12/5 CC was disastrous. Even more disastrous was the last ER CC where he pretty much confessed that RSBQ-AUC in Avatar was a last-minute made-up endpoint to hide the trial’s failure on RSBQ!! He lost all credibility then.
Nope, it’s not common sense to wait for 3 years to release full data — especially to wait for a trial from another indication to complete!
No, it’s not common sense.
It’s hoodwinking.
Of course. It’s all my opinion. But it’s just simple common sense.
You’ll feel at peace once you accept the P2b/P3 trial to be P2 (as is extremely likely the case). Then, all will make sense (companies don’t typically release all data about P2 —- esp not the negative ones).
For now, yes. If RSBQ-delta fails, I’m sure he’ll switch to RSBQ-AUC again …
Cash in some bank.
SVB has less to do with debt but with cash deposits.
Does AVXL have any exposure to SVB, and/or other small banks that could possible get caught in this SVB-initiated mess?
Yup, not looking good.
But a retrace to $10 (13ema) is not bad.
Not rebounding from here would not be a good sign …
Wow. What an imagination.
I have a totally opposite view. This closes above $10.5 today. Let’s see.:)
Agreed, neither is the statement cause for legal action against the company/CEO, imo.
AF’s criticism and skepticism is very valid and justified. Onus is on AVXL to prove him wrong.
Yes, but it’s a very positive sign. It signifies that there would likely be no more screwups. A big positive step announced formally.
I prefer slowly rising volume — so that the rise last multiple days.
Good close. Increasing volume.
Nowhere close to my now-dreamy prediction of 10.5, but close at HOD is always a very good sign.
Generally positive action lately. Hopefully, we see $11-12 very soon — and THEN the volume come to break it out.
My implicit hunch is that volume will come in today — over 1m. Let’s see.
Delays are not catastrophic or unusual.
Delay per se don’t bother me much. What bothers me are the implications of any — Eg, delays of TLRs or explanations of data inaccuracies.
I wish I could place a bet with you on this one.:)
I think this will touch/cross 10.5 today, which will be a big deal.
The drug was eventually approved using dystrophin expression. But, during the application and in pre-NDA discussions, FDA was open to and did consider 6MWT as well as an intermediate clinical endpoint (even though, 6MWT was also regarded then as a primary endpoint) — this was just FDA’s flexibility with Eteplersin. Currently, FDA considers NSAA as the primary endpoint (eg in the current gene therapy trial).
So, it’s up to FDA what endpoint it may allow to be considered as intermediate endpoint (there are no strict or legal rules, as I understand).
I agree todays action was good. In fact — the last 4-5 days action has been positive. It’s itching to go to $11.
Intermediate end-point doesn’t need to quicker (though that is indeed the original intention) — it’s all up to FDA. For SRPT’s Eteplerson drug in 2016, I know FDA did consider 6MWT as an intermediate endpoint (even though it’s pretty much a final clinical endpoint) — but eventually approved based on the surrogate biomarker.
Couldn’t agree more.
That's fine. My only assumption is that it take a day -- at most a week -- to do the dosage-arm analysis. Taking 3 months means -- they don't have anything interesting/noteworthy to report, and they are just doing various subgroup-analysis, data mining and engineering -- to come up with something positive. Just like they did with RSBQ-AUC!
3 months is nothing from an investment time perspective.
But it’s an eternity from the perspective of “time to get dosage-arm” data — and thus implying that there is nothing noteworthy there.
I said “more than anything else”. It’s silly to be looking for other clues — Eg why was Kun hired?! It’s completely irrelevant in face of this 3-month silence.
A trial being a “success” per the CEO is very very different from data being approval-worthy.
Silence from CM for 3+ months after having the data — speaks more than anything else.
That there is nothing approval-worthy in the dosage data — which was the last hope of any pivotal chances.
I’m more convinced than ever that P2b/P3 data is not approval worthy. Fine. But it’s very frustrating to be in dark and/or kept guessing.
Likely, he joined because he sees a long-term potential. No one denies that.
Kun joining doesn’t add any credibility to P2b being pivotal. I just hope that his joining fixes the communication problem — am not very certain, it will.
AVXL’s timeline (per their recent ER CC).
1. FIRST, gather “full” data. How long will this take? CM says: too immature to ask at this point (2/22) —- which imo means 6-24 months from now.
2. THEN, talk to FDA.
3. Decide on P3 vs NDA. When? After #2, I am sure.
Make your own judgement/assessment.
Mine is: P3 is needed and will start in late 2024 or likely 2025.
Yeah, right. It’s also planning a mission to Jupiter.
Yes.
If a trial were pivotal, AVXL would be focused on filing an NDA (Ie, talking to FDA immediately, etc) rather than taking months/year *after* data availability to gather “full” data.
If AVXL publishes before NDA, it is obvious to me that data is not approval-worthy even in their minds.
I just now hope AVXL isn’t going to take 2-3 years to start P3 (as they did with P2b/P3). They likely will.
Irrespective, that means that the trial P2b/3 is not pivotal. In that case — P3 start is much more important than P2b/3 full results. In particular, I hope the upcoming P3 plan is explicitly approved by FDA — including the endpoints, dosing regimen/titrations, etc etc.
When would P3 start? 2024? Or 2025? I’m presuming 2023 is beyond hopes
2 years is indefinite for all practical purposes.
Let me try one last time. Since, it's really a moot point at this stage, no point discussing this further.
1. FDA will not approve based on delta-improvement in Cog or ADL endpoints, for many reasons: (i) The P2b/P3 trial's endpoints were ORs (as per CM, so let's accept that), and not Cog or ADL delta-improvement. (ii) delta-ADL endpoint likely failed, and delta-Cog endpoint likely has too high a p-value.
2. Can FDA then approve based on ORs? I believe that FULL-approval based on ORs is extremely unlikely since it's not an established end-point (i.e., not the clinical endpoint for AD that FDA accepts).
3. Can FDA do an AA based on ORs? This is plausible, since FDA can look at OR as an intermediate endpoint (for AA purposes), and ask for a confirmatory trial that shows delta-Cog and/or delta-ADL improvement. However, without a substantial n for ORs and many other negatives, this too seems unlikely imo.
Lastly, AA is not a mechanism to allow for subgroup analysis. AA only allows for use of a surrogate biomarker or an intermediate endpoint --- that's it. The evidence threshold/bar for the surrogate biomarker or an intermediate endpoint is as high/stringent as in the case of clinical endpoint for full approval.
If you are still unclear, or disagree -- never mind. As I said, it's a moot point, and not worth wasting time on discussing it.