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Oh, that's right... you're still here because you're paid to FUD here.
Sorry... no heart for paid FUDsters.
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?
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.
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.
Nope... it was clearly your FUD comments about expecting "cherry picked" Rett data, that made it very clear that the short-n-distort game is still on.
Thanks for showing your 👺 hand.
Yep. Saw this coming... started calling it back in Nov when Investor was already talking "cherry picked" expectations. The fabricated takedown with the Rett TLR would happen regardless of the results. It's what the AF/HF cabal do every time. So, selling a large tranche around $10 was an easy decision, at the tested resistance, after they ran it up from $5... and then just waited for the Rett readout to drop. With 18M collusive shorts outstanding, the cabal will bring it down every time. They're very predictable... and the FUDsters are quite easy to read.
The shorts days are numbered with approval coming this year. Now's the time to (re)load up!
Just look around... there's plenty of "signal" in all of the trials, including QOL, improved sleep, mood and biometrics... all with a very safe drug.
The RAs will have no problem seeing the BIG picture... at least the EMA had no problem.
Unlike you, I'm not part of the collusion. Just an observer and quick learner.
Tell your handlers 👺 thanks for me!
A FUDster 👺 working hard to deflect! Love it!
Yep... this board is overrun with paid FUDsters.
So funny to see a FUDster 👺 come to the defense of his own ilk.
You really think there isn't any corruption happening in the industry?
No doubt. However, there's no reason to give up on Rett now that all the data are available. It's just a matter of presenting it to the RAs and getting feedback. What else do they have to do except to work on the AD MAA filing? Obviously, the AD MAA work takes precedence.
The only crooks are the collusive HF manipulators and their paid FUDsters 👺 who troll message boards daily posting nonsense.
Certainly will be between now and approval, but that's several months away. Should get a good bump once the AD MAA is filed this quarter, then the approval clock starts.
All the Rett data + OLE and RWE will be provided to the FDA and perhaps TGA and MHRA. I believe the RAs will look quite favorably on all of it, with its efficacy and safety profiles.
Knowing that the collusive AF/HF cabal are going to attack every data release, regardless of how good the results are, is most helpful in knowing when to sell... and then wait for it to happen.
To your point, it's more about subjectivity and perhaps bias of the reviewer than it is an actual placebo effect in the patient... who, in the case of Rett, are likely unaware they're receiving a drug/placebo. Also, the reviewers may be hearing biased comments from the caregiver/parent during the evaluation.
Biomarker data will bring objectivity into the evaluation (e.g. gaba & glutamate), as well as QOL improvements, including sleep and reduction in seizure frequency.
I presumed so... there are many making their MB debuts... along with the return of long lost FUDsters for such an occasion.
You're talking to a known FUDster. Beware!
We'll be waiting...
More like BarrellofFUD
There are no "casualties" here; nothing to be afraid of or apologetic about. We're talking about a .01 difference from being stat.sig. in a trial that's based on subjective reviews. What's important is that the girls have improved while taking the drug... better QOL and a significant reduction in seizures, with NO adverse effects.
Missling will focus on these aspects, perhaps add some biometric data, and advise on next steps with RAs... for both Rett and AD