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The tactic of a paid FUDster when he knows he's been cornered. So funny.
LOL. Why are you so obsessed with my conversation with IR? I think you're concerned that we talked about you and your handlers. After all, you are the biggest 👺 on the list... which I emailed to him.
You're an obvious paid FUDster, because no true investor would bellyache the way you do, ad nauseum. True investors know who controls the SP and it's not Missling... it's your handlers.
It'll be another sad day for you when you've been proven wrong again, just like your Febish prediction for Rett results... FUDster
Funny how you changed the subject away from the AA clock-stop topic when you realized you were, once again, shown to be wrong.
It's rather apparent that the pre-submission mtg happened last year, FUDster.
So many FUDsters with reading comprehension problems...
He said it would make sense if PDD would be included in the peer-review, since it is closely related to AD, but he wouldn't confirm it.
Why would a true investor have an issue with that?
NO, FUDster. The request can come when they submit the MAA.
Wow, you're really grasping at straws, aren't you.
Knock yourself out, FUDster. Are you worried that we were talking about you?
Is it a reading comprehension problem you have, or just a persistent FUD narrative?
Don't you understand that "overall" is weighted primarily by the normal lengthy process? Few drugs qualify for the 150-day accelerated assessment procedure. Those drugs are novel and meet an urgent unmet need. Blarcamesine certain fits the bill.
Read the procedure again... there's only ONE clock-stop for one month.
Though you'll continue with your negative FUDster narratives, the reality will be that blarcamesine will qualify for the AA procedure.
My first conversation with IR. I found the guy open, honest, pleasant, engaging, and upbeat, yet guarded about answering anything that's not public information... though I tried. I very much liked his candidness, especially his comments about the collusively organized HF cabal and particular individuals. We're certainly aligned there.
Are you ignoring that the EMA's 150-day accelerated assessment procedure only has one clock-stop of one month?
Sorry, Adam, you'll have to take your FUD elsewhere.
One has to question if it's even sincere moaning, or paid theatrics.
I think it's rather obvious.
I'm sorry, did your toes get stepped on? So, where's your list, FUDster?
You're sounding quite desperate there, Adam. LOL
Maybe if you produce your supposed "paid pumper" list I'll let you know.
That's a valid idea in theory; however, many are here because it's a job (if you couldn't tell).
Haven't you noticed that most biotechs are in the red today, including the XBI?
Whining when the XBI is also red is not a good look, mikey.
Evidently, not "just"... just an oversight. I need a better CRO.
How did you slip through the cracks? Updated list coming...
I'm betting this qtr, perhaps this month, for publication.
It would validate and accentuate the MAA submission if publication comes before.
It hasn't started. The MAA has to be submitted, first. I'm expecting that to happen by the end of March, hopefully sooner. I would think that much of the boilerplate sections have already been completed.
11 months is a long time.
You can put me down for Aug/Sep if the MAA is filed by March.
Rett is a wildcard... it could still surprise with quick approval given the need, and all the evidence.
No schitt, Sherlock. The MAA hasn't been submitted yet! SMH
LOL... aren't you off your rocker today! Keep it up FUDster; you're showing your true colors with your wild and crazy swings.
Matter of fact, he was sharing HIS thoughts to me about your "team".
So, when are you going to provide us the long list of supposed "paid pumpers"? LOL
Don't worry, Leo, we didn't specifically call you out... but can't say the same for others.
For those having trouble finding or talking about the EMA's 150-day AA procedure, here's the process... which includes one "clock stop".
Hey a-hole, can you provide us the details of the EMA's 150-day accelerated assessment program?
Let's just say that they are very aware of the organized effort to short and distort and who the key players are. We had a good conversation about that.. at least 10 mins worth. That's why I interjected with his belief that the peer-reviewed journal article should diffuse the organized naysayers (putting it politely). And if they are going to continue to attack it'll be attacking all the qualified experts, which will make them/you appear even more ridiculous, if possible.
I talked with IR this afternoon (approx. 30 mins) and had a very good discussion on various topics, including the antics of the organized collusive HFs (cabal).
The key takeaways on Rett were that they will be following up with the FDA with both the AVATAR and EXCELLENCE trial data, OLE and RWE data and results, pursuing approval. It was also conveyed how supportive the Rett Syndrome orgs have been and eager for blarcamesine to be approved. This should be a tremendous help for Anavex's cause.
Regarding AD, he would not elaborate on the timing of the MAA, but confirmed it's being diligently worked. I asked about requesting the 150-day accelerated assessment process and, though he wouldn't say explicitly, he reassured me that the team is on top of it. I asked about AU and UK, and his response was that EMA and FDA are their primary focus. He's very much looking forward to the peer-reviewed journal article being published, which will diffuse the organized naysayers. He couldn't confirm if it'll also include the PDD data or not, but would make sense if it did.
They're very excited with their developments to date (with more happening behind the scenes) and feel they're in a very good position to get to commercialization in a reasonable timeframe.
I simply present the EMA's accelerated-assessment program and I'm called a "paid pumper".
So hilarious... and typical of how a paid FUDster would respond.
Okay, so let's compare lists of your so-called "paid pumpers" and the list of actual paid FUDsters.
I'll go first with the paid FUDster list... (Oh, look who's at the top)
The FUDster very well knows that. It's just his job to accentuate the negative and twist info into a FUD narrative.
Hey FUDster, I conditioned my response as "pragmatically optimistic". You should've conditioned your post as "extreme pessimism".
So obvious your intentions that you don't mention the 150-day process, until I posted it.
Leave it to a FUDster to spin it as negatively as possible.
Hey a-hole, do you know anything about the EMA's accelerated assessment process?
Of course, a FUDster wouldn't want to post anything about the following process for accelerated assessment, would they?
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-and-practical-arrangements-necessary-implement-procedure-accelerated-assessment-pursuant-article-149-regulation-ec-no-7262004_en.pdf
I'm presuming the LOI was submitted several months ago... prior to when the EMA reviewed the data and made their MAA recommendation. It's why Missling stated they will submit the MAA as early as possible in 2024.
We can always count on you for the FUD spin.
The "clock stops" aren't automatic; they're if needed.
If the MAA can be submitted by end of March, then under the special 150-day review process, we could see EMA approval for AD by August. That's the pragmatically optimistic viewpoint. It's also likely that an NDA will be filed for AD, and possibly Rett, in that timeframe. Then there's AU and UK, too.
There you go again, FUDster. Just so you know... $10 is were bas sold a large position in anticipation of the organized Rett TLR short attack that you signaled last year, with your "expecting cherry picked results" post. Thanks for that! Sub $6 is where bas reloaded. Now waiting for MAA, followed by MA and commercialization.
You do love to spin false narratives, don't you.