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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".
Accelerated Assessment Procedure
- Day 1 Start of the procedure.
- Days 1 – 90 First assessment phase:
• CHMP Rapporteurs’ assessment reports
• PRAC Rapporteur updated assessment report
• Peer-review
- Day 90 CHMP plenary meeting with adoption of either:
• CHMP positive opinion; or
• CHMP list of questions to the applicant to be addressed in writing and at an
oral explanation if necessary with maintenance of the accelerated
timetable. The CHMP may also adopt questions for a Scientific Advisory
Group, as applicable; or
• CHMP list of questions to the applicant to address in writing and at an oral
explanation if necessary with switch to a standard timetable (see 5.3).
- Stop of the clock: One month stop of the clock by default.
- Clarification meeting will be planned shortly after adoption of the list of questions.
- Day 91 Restart of the clock following submission of the applicant’s written responses.
- Days 91 – 120 Second assessment phase
• CHMP and PRAC assessment report of the responses
- Day 120 CHMP plenary meeting with adoption of either:
• CHMP positive opinion; or
• CHMP list of questions to the applicant to address in writing if necessary
with maintenance of the accelerated timetable; or
Guideline on the scientific application and the practical arrangements necessary to
implement the procedure for accelerated assessment pursuant to Article 14(9) of
Regulation (EC) No 726/2004
• CHMP list of questions to the applicant to address in writing and at an oral
explanation if necessary with switch to a standard timetable (see 5.2).
- No Stop of the clock: The CHMP would request the submission of the written responses without clock-stop
- D121 Submission of written responses
- Days 121 – 150 Third assessment phase:
• CHMP and PRAC assessment report of the responses
- Day 150 CHMP opinion
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)
Biochecker4 (voted biggest 🤡)
Investor2014
DoTheRightThing
kund
Reyeton
jav0033
poguemahone
go avxl
mrplmer
crescentmotor
attilathehunt
CashMoney75
loyalinvestor1212
SquealingSquid
ExtremelyBullishZig
JKS3
Kb1123
Rikker19
PsuLion
growingpain
Inquirig
Spudskie
tootalljones
Anshu2
OFP
frrol
Doc328
LakeshoreLeo1935 (voted 2nd biggest 🤡)
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
Accelerated assessment is a regulatory tool supported by the European Medicines Agency to shorten the centralised procedure review period of a marketing authorisation applicant from 210 to a maximum of 150 days for medicinal products of major public health interest particularly from the point of view of therapeutic innovation.
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.
An NDA/MAA filing is 100k pages or more. It takes time to compile it all correctly.
I expect it'll happen this quarter.
Well, if investors won't sell, then the crooks have to run the stop-loss orders to get shares. They have a ton to cover before approval!
Which shorts want to be the last to cover?
The approval clock is ticking!
The collusive cabal (MMs/HFs) know this is their last opportunity to attack the price prior to approval... from where they'll have to start covering their collusive short position. It's always darkest before the dawn... and the corrupt manipulators never fail to make it so. Time to buy!
Your FUD attempts are quite weak. It's hard to believe that someone actually pays you for them.
Perhaps more FUD training might help. Call AF.
Why do you only appear when your handlers start taking the price down?
Is it a FUD alarm that you respond to? Oh, time to post FUD!
I guess we don't know if the LOI was submitted months ago.
Good post. Also, it's important to capture, both, cognitive and functional improvements... which the trial did with ADAS-Cog and CDR-SB... even if the mean score comparison for the subjective ADCS-ADL measurement wasn't quite stat. sig. in the short 48-wk trial... the CDR-SB score was.
Then consider the two ORs as supplemental data highlighting the strong responders for both cognition and function.
What?
I just wish that Missling would talk about what is current on 2-73 instead of avoiding talking about it
Another for the 👺 list...
Most know that the manipulators want to make it the "darkest before the dawn" (before approval). Thus, this fabricated downward pressure is merely an opportunity to reload and/or buy more... before the dawn. Those 20M shorts will have to start covering sometime in the coming months... and a surprise partnership announcement would certainly cause quite a short squeeze.
I doubt your handlers would approve.
His only awareness is to try to impress his handlers.
I guess that would leave you exposed...
He's actually harmless to anyone with half a brain.
It's obvious that you're trying harder... 👺
No one can take your most-voted title away. 🤡
FUDsters 👺 out in force today to try to spook retail holders into selling, as we retest support, so that their handlers (collusive HFs/MMs) can begin their short covering. They have 20M collusive short shares that they'll have to cover over the next several months.
I should move you up higher in the 👺 list.
Yes, very much looking forward to the peer-reviewed journal, MAA submission and approval this year!
Those were the company's words.
Did you notice that blarcamesine is 2.5x better than trofinetide, with a much better safety profile? Less seizures as well. Of course you noticed it, but it doesn't fit with your FUD narratives.