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You would know better than me. 👺
TSHA is only down 4.4% on that news.
I'm fairly certain there's an embargo in place. Most all science journals have them. It's very likely the reason we haven't seen the AD study details.
Emotions blowing with the wind. 🙄 It appears to be down with the XBI... until it changes.
It's a red day across the board, mikey.
Don't worry... short covering will continue, little by little, then the big upward crescendo near approval.
My job is to call out the nonsense FUDsters. Period. Reasoned concerns are totally acceptable, but that's not what we're getting from FUDsters... instead, purely ridiculous bashing.
If you don't want the stamp, then stop the nonsense posts.
You're earning your 🤡 stamps today! LOL
It's becoming a global crisis of corruption...
👏👏
— kristen shaughnessy (@kshaughnessy2) January 9, 2024
UK Parliament member says PREDATORY SHORT SELLING PRACTICES ARE “QUICKLY BECOMING A CAUSE FOR GLOBAL CONCERN”
“…It is crucial that the rules governing short selling are re-examined and strengthened to mitigate potential damage to pensions and protect retail investors.… https://t.co/Nx1zR472tR
FUD stamps 👺 are only applied to false, twisted and purposely misleading FUD posts.
Clearly, most of your posts qualify.
It's a tough one-man job to keep up with so many board FUDsters... 👺
Biochecker4
Investor2014
kund
Reyeton
jav0033
poguemahone
go avxl
mrplmer
crescentmotor
attilathehunt
CashMoney75
loyalinvestor1212
SquealingSquid
ExtremelyBullishZig
Kb1123
PsuLion
growingpain
3jack
ChrisMissing
Spudskie
Anshu2
OFP
frrol
Doc328
LakeshoreLeo1935 (voted biggest 🤡)
Most of it short covering.
I always apply FUD stamps and clown faces where appropriate. You've been identified. 👺
I believe RAs will review all the Rett data (in contrast to the extraordinary placebo response) and come to the conclusion that blarcamesine DOES WORK EFFECTIVELY AND SAFELY...
‘FDA increasingly approves drugs without conclusive proof they work.’
This article might be helpful...
https://www.pbs.org/newshour/health/fda-increasingly-approves-drugs-without-conclusive-proof-they-work
More recently, Sarepta...
https://www.fiercepharma.com/pharma/after-primary-endpoint-miss-sarepta-touts-clinically-meaningful-trial-result-and-will-seek
Then there's the well-known mab fiasco for AD.
When FUDsters respond the way you do, it reinforces that I'm spot on. It's hilarious to see you in action defending and deflecting... so predictable.
LOL. Hey 👺, show us the "storm" posts you're referring to. We know this is just a deflection attempt by a known FUDster.
LOL. Another 🤡 remark.
It's not unbeatable. On the contrary... the cabal's intentions are quite telegraphed with their chorus of FUDsters, as one of them will eventually show their hand. In this case, Investor.
Keep trying harder... you'll get there.
Waiting for the manipulation to settle out, then start reloading again.
It's not the "market"; it's collusive manipulation... they pumped it up to $10 and then sold/shorted it back down.
They have 18M collusive shorts to cover. They're not going to cover them at $10+, when they can take it lower, behind a smokescreen of FUD.
Oh, that's right... you're still here because you're paid to FUD here.
Sorry... no heart for paid FUDsters.
no basis in evidence.
LOL. I don't need any help. I can spot paid FUDsters a mile away.
The defensive denials from the FUDsters are evidence enough. Thanks for continuing to show your hand.
Fabrication? Like fabricating the need for a PM Ph3 AD trial?
That can be said of your posts... no proof! Just spin!
About time... Bye!
Agree... though the placebo measurement was unbelievably good, the treated response was still significantly better, in addition to all the clinically meaningful (QoL) improvements.
Comparing RSBQ improvement between blarcamesine (-12.9) and trofinetide (-4.9) is quite telling even if they ARE separate trials... even the RS-003 placebo improvement of -8.3 was better than trofinetide.
Would you like me to explain it to you?
Although data analysis is ongoing, the early conclusion is that the placebo rate could have been higher in the study due to a slight imbalance in disease severity at baseline, across the treatment arms, and the 2 to 1 drug to placebo randomization ratio. We intend to further assess the collective results and discuss with the regulatory authorities next steps.”
When looking at other placebo-controlled Rett syndrome trials, ANAVEX®2-73 compares favorably in terms of absolute RSBQ improvements, with the caveat that cross trials comparisons have their limitations.
The purpose of posting the successful trades, as a result of predicting the collusive manipulation by your organization, is purely to let you know that we've got your number, that your short-n-distort FUD campaign is much too obvious, and well... just to piss you off. I see it worked. LOL
One explanation was provided by Anavex... the placebo arm had more mild diseased patients.
Also, compare the RSBQ scores of blarcamesine to trofinetide. Quite a contrast.
It would be a true disappointment and failure if the endpoints missed an expectedly "normal" placebo response of little to no improvement. If the placebo response was "normal", blarcamesine would've clearly exceeded in meeting endpoints and the trial would've been a resounding success.
Obviously, that didn't happen. Instead, the trial got hit with some unfortunate bad luck with extraordinary placebo scores. However, it's not the first time a Rett trial has experienced this... and the reasons behind it are quite plausible. It's not a true placebo effect with the patient, where the patient realizes s/he is taking a drug and believes it's helping him/her. Rather, it's one that's expressed and influenced by the parents/caregiver... and that positive "hope" and belief are conveyed to other Rett parents, as well as the reviewers. It's rather normal for this "bias" to happen... more so with pediatric patients than with aging AD patients.
It's not the first time the FDA has experienced this phenomena... and is why they frequently approve a drug in these circumstances, especially a safe drug. They review the entire package of trial data, OLE and REW information in the approval process... not just the p-values.
Not concerned at all about the prospects of approval for Rett... and AD.
How would I know the answer? I don't work for Anavex.
You want more predictions?
MAA submission this quarter.
NDA filings for Rett and AD in H1 this year.
Investor2014 and the rest of the nefarious FUDsters 👺 will be gone when approval comes this year.
Your actions are exactly what the manipulators (collusive MMs/HFs) and their FUD brigade want everyone to do... sell! When you sell for a loss, then they win and you lose.
Blarcamesine WILL be approved this year.
From Piotr...
https://www.patreon.com/file?h=95835549&i=17186530
Conclusion
1. The bias present in the RS-003 placebo arm toward seeing improvement in girls was excessive and unpredictable.
2. There is a question why there was such excessive bias toward improvement in RS-003 placebo arm? Is there any plausible explanation? Could be networking among the families of girls?
3. This reminds for the failure of BioVie, due to no fault of the drug or the company.
4. It is very likely that $AVXL might reach out to regulatory agencies with the available data for special treatment. All due to the case of a better drug failing trial due to misfortune placebo arm.
Conclusion
1. The bias present in the placebo arm toward seeing improvement in the girls was excessive
and unpredictable.
2. The inherent dispersion of the RSBQ scores prevented reaching statistical significance
together with the biased placebo arm.
3. Effect Size Cohen’s d is a better measurement to approve drugs than p-values.
4. Blarcamesine should be approved for Rett syndrome
Conclusion
1. The study was correctly powered and had ample margin based on the experience in trial RS-001 and its analysis.
2. The outsized improvement in placebo arm, both unpredictable and probably false caused the study to fail reaching status of statistically significant.
3. The statistical significance was missed by a small margin due to large therapeutic effect still present in spite of the disastrous placebo effect.
Clearly, it's a job... as with all FUDsters here.
Not a waste of time if the FDA is impressed by the complete package of trial data, OLE and RWE evidence. Agree... AD is priority #1, but that doesn't mean drop Rett.
Sorry, but Rett didn't "fail"; it just wasn't completely stat.sig... and there's an understood reason for it. The FDA will be impressed with the BIG PICTURE.
The "placebo effect" comes in the form of overly hopeful parents providing encouragingly positive feedback to their daughters, believing perhaps their precious girl is on the beneficial drug. You can't blame them, though; it's only natural. I'm sure those hopeful and positive feelings were on display for the reviewer.
Seeing the BIG picture, I don't believe the voucher is gone at all...and very much in play.
" If the excuse for not pursuing AD with the FDA was the voucher, that excuse is gone."