Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Even if (it’s certainly possible) OR was indeed the intended outcome measure (as claimed by CM) — FDA would still like to compute/analyze the mean-change from baseline. If the mean-change from baseline is worse than placebo (without regards to p value) , IMO FDA will not approve.
OTOH, if
1. OR was indeed the intended measure, and the p-values for ORs are satisfactory, and
2. Mean-changes of COG and ADL wrt placebo are positive (even if the p-values for the mean-changes are high)
Then, FDA *will* consider the NDA, IMO.
IF it rebounds today by 4pm — there won’t be any stopping this baby.
Could they again make-up new endpoints/measures for the EXCELLENCE trial?
Should we ask him upfront extremely clearly — what the statistical measures will be for excellence?!
I'm here. Yes, I predicted it to go up over 1-3 days. It's only 1/2 day. Plus, predications can't be exactly right ... let's see what happens over the next few days. Then, you can say that my intuition/prediction was wrong -- sure.
Isn’t it obvious? Never — except in a peer-reviewed journal which could be 1-2 years away.
I’m thinking of buying more myself for a 1-3 day move. Esp if there is pullback early morning ..
Most times the stock trading action is contrary to what we think it should be (of course, otherwise we would all be very rich).
With that said — my prediction is based on technicals. AND, imo it doesn’t conflict with fundamentals (even with assuming the trial is not pivotal).
Fundamentals is for long-term. For short-term, best to trust the technicals.
Eventually — it’s not that I’m right all the times. But I do have a good sense of technical strength of a stock. At THIS point, it’s almost a near certainty (in my eyes) that it’ll go up from here …
IMO, the stock's trading action (i.e., technicals) is just TOO AWESOME. Which means -- it will continue to go up, until some news comes out. I'm thinking $13-15.
Fundamentally -- it's fair to assume that the 2b/3 trial was not pivotal. With that said, it's not easy to put a fair valuation number. It could still easily be worth $1-2B, Which is $12-24.
So, with no news on the horizon -- the stock will trade based on technicals for a few weeks. At THIS point, it seems to be headed up...
The stock is NOT moving with the market. You can take a deeper look.
The problem is with our hopes/expectations of the last trial being pivotal. It’s not. With that acceptance, almost all issues go away.
Correct about the positive part of my prediction. Only means that this is heading to $13-15 very soon. Very strong action today!!
Unbelievable that this is $11+!
Btw, it’s not indisputably true that the endpoints/measures were not ORs all along.
What could be the advantage of buying $3 Jan 2025 calls compared to the common stock ($10.6)? Common stock is like $0 Jan 2050 calls! :)
High-volume churning today is a good sign. People getting out/shorting are the ones who were expecting news at JPM, while people buying must be ones betting on future releases and/or potential. I’d bet on the latter being more knowledgeable— especially considering the superlative trading action of last 1-2 weeks.
In spite of all the CM’s bads, AVXL can still be a huge success — 5-7 years from now.
It’s a phase 2. Then, everything will make sense.
Zero chance of the past AD trial being pivotal. CM has accepted it in his mind.
OR outcome measures is final. Get over it.
No urgency with anything (full data in peer-reviewed journal?!).
It takes the company >7 months (!!) to get full data? Eg, why no data per dosage arms??!!
Key statement:
ONCE WE HAVE FULL DATA (including .. blah blah blah), we will immediately meet with regulatory agencies around the world.
So -- meeting with FDA is at least a year away!!
In CM's mind -- there is nothing incomplete about the data. Thus, no hope for anything more -- - until a peer-reviewed article, if at all.
Haha. That sounds like CM!
At most a week, after they have the data. Maybe, not even that — since CRO gives the data with all the analysis I presume.
What possible excuse?
To not have shared (near-)COMPLETE data by now?
Anything other than “it takes time” (because it doesn’t take more than a week!)
It’s not half-time of the final game. It’s the beginning/middle of the group stage.
I’ll buy more — only if some of the most skeptic (who are incidentally also the most sensible) of posters turn positive. There are only a handful here.
Yes, but at the very least — the JPM presentation gets him speaking to the “world”. Would he not clarify the confusion from the last TLR, in some shape or form? I can’t imagine otherwise — but again CM doesn’t disappoint in disappointing!
Tomorrow can’t possibly be nothing-news!
But what if it is …. How shameless can CM be? Just give a corporate presentation without first clarifying alleged-falsehoods he has broadcast a month ago ..
Could he be that shameless?
$7.5 to $10.8 is a very non-trivial rebound.
There is CERTAINLY something positive going on — perhaps WS/potential suitors’ interest. OR, some news coming out tomorrow.
Irrespective, my faith in CEO and his ways is so eroded that I’ll sell 25-50% of my position in $13-15. I sold a bit today (which I had bought mistakenly on the way down).
Wow. You have high expectations.
The company is no where near that stage of planning/organization ability.
Doesn’t matter — how many people are there. What matters is what he says.
#3 is IMPOSSIBLE.
Have you ever seen that from AVXL for any of its trials?
Can’t dispute the beautiful trading action in AVXL.
I just hope the reason is deeper than the hope for something on 12th — which will be certainly disappointing.
Perhaps, the reason is buyout potential/interests and/or Selvaraju high target.
Shorting is MUST to have trust in the system.
Right now I don’t believe in stock manipulations—precisely because I can short it (if others are possibly hell bent on manipulating it, I can even profit from it — so no point complaining).
Allowed to short — essentially means the system can’t possibly be “rigged”.
Will never happen, unless CM resigns.
40 days of not being able to clear the cloud!
I actually don’t “blame” the data — since such is science and outside our control. Trials fail — but that doesn’t doom the companies. Look at SRPT — it will have a very bright future in spite of a very big failure in 1/20. Same for BMRN.
I blame the CEO — for eroding ant trust left in the words that come out of his mouth (and failing to deliver any complete TLD from various past trials). And, THAT is the biggest setback that is under company’s control.
Yes, it does. AVXL scientists have all the reasons to fake research.
More than a month gone, and no corrections/clarifications/amendments to the TLD/R that caused huge confusion and allegations of false food in the market.
Also — why should the CEO wait for a JpM presentation — to clarify or present more data? It’s not as if JPM is a journal/conference.
Nothing will come out for months.
CEO talk.
Should have listened to SRPT CEO Ingram talking at JPM — so transparent, confident, and very inspiring.
I wish CM were anywhere close … he can be … but needs some basic guidance.
Technically, looks awesome. I predict $11-12 before 12th — after which it will likely crash!