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“there was Millions invested in this stock in the beginning of the week because you promised and guaranteed the peer review would be printed for all of us to see and great news”
Shirley you can’t be serious …
AVXL should stop applying for patents. It is just a tactic to distract investors from the fact that the drug is a sugar pill.
Yeah, good luck with that. It’s amusing that you can’t see that your ludicrous negative spin on every single conceivable issue is as ridiculous as George’s 100% positive spin.
Ironically, your odds of approval based on a Phase 2 schizophrenia trial are as baseless as George’s.
I was talking about the broad market. Yes, I’m aware of your sales pitch on AVXL. Not particularly interested.
I think the overall market is going to be soft for a while. The administration and the Fed are living in denial with the inflation. That whole recent rally was based on a fiction.
You seem to not be considering the market meltdown today. Particularly this sector.
You may want to look at the indexes.
Basically. But he doesn’t criticize SAVA for this, naturally. Hence my question to him. Which he didn’t answer.
Here is a quote from your post:
What is not debatable is the continuing absence of a regulatory approval leading to a successful commercialization.
Wow, I just assumed that was a label, not an actual name. This is kind of like naming McDonald’s Corp. “Large Fast Food Company.”
I know you are aware that there can only be an approval after an application is submitted. Which they are working on for AD.
Has SAVA had any successful trials yet? According to your definition of only approval=success?
Which company has had a more successful potentially pivotal trial for AD than AVXL, with one primary endpoint and one secondary below p .025, ironclad reduction in brain volume loss, a stellar safety record, with oral dosing as opposed to injections, no brain bleeds, no MRIs required, etc.?
It’s a generic name. They apparently don’t want their true name disclosed.
Interesting that you’ve become an AVXL basher and a SAVA pumper.
The Bobbsy Twins are working OT this weekend. Time and a half, according to federal labor regulations.
Thank you, George.
How certain are you, George? Should I buy more?
Clearly incorrect when he states that the FDA has provided guidance regarding next steps for our AD. That was early in the article so I stopped reading at that point to avoid wasting my time.
Not what he said. He said another trial is a possibility but left open the possibility that the FDA might consider an NDA filing. Either way it is clearly not “ dead.”
Okay, you’ve convinced me you are probably correct.
I guess the question is, then, would the peer review paper be considered a “brief statement” of the trial results?
Others may know better than me but I doubt there is any formal process for seeking FDA guidance. I’m guessing they simply say “Whaddya got for us?” The peer review would address that nicely.
I doubt they even need to sign an NDA. I assume non-disclosure is a standard rule for the FDA.
The peer review in its first form was likely only completed recently. No reason to wait for it to be published before giving it to the FDA. The FDA may be reviewing it in prep for a meeting.
I was being polite.
I’m sorry that all of this upsets you. I already know how we got to this point. The EMA said “file” and they are working on it but are unsure exactly how long it will take. They are planning to meet with the FDA for guidance on both AD and Rett but don’t know how long it will take. I suspect they have submitted the unpublished peer review and then there will be a meeting.
Unlike you, none of this causes me any angst. To each his own.
I see it simply as Missling not knowing how long it will take. He cannot disclose what he doesn’t know.
None of the above. I call em as I see them. The sales have sucked. Although there is a ray of hope with the unaudited numbers. But we should be doubling revenue quarter over quarter at this point. I hope it happens but the jury is out.
I’m also curious as to where and how we are going to raise badly needed cash, with the VCI deal falling through.
That is correct. I see no problem with an inability to predict uncertain timelines and an inability to disclose every little task and communication that these processes involve.
I’m not trading so I don’t need to try to time the market. I can wait for events to unfold.
Two interesting issues. Particularly the one about whether Evan will be demoted or step down from CEO. It may be that if the VCI deal went through he would have been replaced.
I agree with him on the AI issue. It’s dangerous and unpredictable. But not really in the context of creating 3D models.
Happiness about the information provided has nothing to do with it. The MAA submission, for example, which I’m sure is a very complicated give and take process, is being worked on. If he cannot give an exact timeline I understand and accept that fact. I’d rather this than get another time prediction that he is unsure he can meet.
Same goes for the FDA process, peer review, etc., in my opinion.
I would prefer, and expect, that we’ll get an update when it is available instead of waiting for the next earnings call.
The PR today about unaudited earnings numbers is somewhat encouraging, at $5m in revenue. They need to double that in 2024.
Yes, we can drop it. I only hope that people in the future don’t get too upset when material developments are only reported when they actually occur, as opposed to on a specific date that happens to fall every three months or so.
You apparently miss the point of the discussion. Which is why, supposedly, the earnings report is some kind of inflection point. It is neither a deadline nor a point in time that has any significance.
Non-sequitur.
Wow, impressive. So many words, and so little sales.
Analogy: wait, let me tell you about how efficient we are at making pizzas that nobody buys. They are quite delicious and although we are about to be evicted from our store by the landlord because we ran out of cash, our production of unsold pizzas is now extremely efficient. In fact, we are buying another oven to produce even MORE pizzas that nobody buys.
It’s okay, though, because the pizza market is huge. We haven’t captured any of it but the size alone is impressive. It’s kind of like a large mansion that you can admire but never have.
That doesn’t answer my question of why a new development would likely coincide with the earnings call such that it would be disclosed for the first time. For example, the EMA development occurred so they PR’ed it already. Should they have waited until the earnings call just so they’d have a shiny object to present?
Why do you assume that Missling would hold off reporting something new until an earnings call? Or that a new development will happen to occur nearly simultaneously with the earnings call? I’ve never understood this assumption.
Generally earnings calls are interesting for mature companies because the companies discuss … well … earnings. Which AVXL doesn’t have yet. How many companies announce material new developments—other than financials—in earnings calls? It’s rare.
Which of the 42 employees do you view as being “3rd rate greaseballs?” I’m still laughing several minutes later.