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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
The collusive cabal were waiting for the Rett readout to attack any kind of results presented. Lucky for them they got something they didn't have to lie about (well, not have to lie a lot). So that was very much expected... and some here took advantage of it.
The next PR will be something the cabal won't be expecting... but that won't keep them from FUDing about it.
It'll give Missling the ability to provide more information at the conference.
You failed to mention all that I said... that it COULD be approved in 2023 IF the NDA was filed by June 2023.
It's clear that an MAA will be filed as early as possible this year (likely means Q1). The EMA won't take more than a few months to approve it.
Success comes with approval this year. Mark it.
I think we'll see a PR right before the conference.
You'd be wrong about that... If SAVA, or another biotech, improved QOL for Rett girls and reduced seizures, I'd be positive about its prospects, regardless if the endpoints were barely missed... and likely would invest on the overreacted price takedown. It's about the big picture, not the p-values.
In spite of the near miss for Rett, Anavex is doing just fine... and will have approval for blarcamesine this year.
Chin up, Mikey. Approval is coming this year... a few months after EMA MAA submission.
Who knows, perhaps an NDA filing as well... for Rett, AD or both.
I'd be accumulating at this point... as those 18M shorts will be covering at some point between now and then.
Are people aware that medical books now have drug ads in them? What does that tell you about how the profession is being "guided".
BP propaganda to the max!
You can interpret it however you want, but the EMA gave permission (green-light) for MAA. FACT!
I know your handlers want your to FUD on everything positive. 👺
What? This makes no sense...
Don't fall for the FUD propaganda...
You can take up to 15g/day of glycine (3g at night); however, I only take about 5g/day, because I consume eggs and meats which are good natural sources of glycine.
2.2-lb bag of the glycine powder from Microringredients is $27
2.2-lb bag of NAC from Bulk Supplements is $46
The benefit of niacinamide (aka nicotinamide) over niacin is that it doesn't contribute to flushing.
Only need 50mg 3x/daily (150mg total), though the label says 500mg. It's very inexpensive in bulk powder form.
8.8-oz bag from Bulk Supplements is $16 and will last for years.
Good luck!
I still maintain that the dropouts were primarily due to parents withdrawing their daughters from the trial because of the applied vax mandate by some of the sites.
It's only disappointing that randomization and "placebo-effect" skewed the results. Otherwise, it's clear the drug is safe and effective... as we'll soon see when all the data are provided. The FDA won't have any problem approving blarcamesine for Rett.
I'm sure the FDA will see it this way, too, in addition to the QOL and seizure reduction that blarcamesine safely provides.
Did you look up the information on clinicaltrials.gov, before you posted your nonsense? 🤡
Is this from the same people who claimed gingivitis was a likely cause?
I provide free advice right here every day! Just watch the FUDsters in action. $$$
Correct... FUD posts are just smokescreen for the coordinated action behind it. 👺
After buying a big chunk at $5 and expecting your handlers' attack on the Rett readout (regardless of the results), don't you think I would've sold a big chunk at $10?
You're too funny. 👺
There's always these particular posters who'll come to the defense of the conspiracy minded cabal. LOL
We should be getting Seizure Frequency data from the trial, in addition to Motor Behavioral Assessment and Children's Sleep Habits, plus all the biometric data.
That question wasn't to you.
12.93 pt drop vs. 4.9 for Daybue. Those are the numbers... 2.64x
Why wouldn't Daybue have similar placebo effect as blarcamesine?
Okay 🤡
The point is we were expecting the collusive takedown regardless of the results.
The FUD cabal didn't fail us!
Hey 🤡, go back and look at my posts predicting another orchestrated collusive take down with the Rett results.
You don't think we weren't waiting for this?
Certainly, the numbers made it easier for them, but it would've happened in any event, because it's how the FUD cabal operates.
And you know this.
I would expect 18M shares to start coving well before the EMA approves blarcamesine this year. They need to get out ahead of the coming institutional buying.
Only because of randomization and a strong placebo-effect (and/or positive bias), the results didn't show stat. sig., but clearly is better and safer than Daybue.
Like I said... the Rett results would've been attacked even with great stat. sig numbers, behind prepared hit pieces by AF and our board FUDsters. It's what they/you do every time. We know what we're dealing with and smart investors will learn to recognize it, expect it and play it.
Thanks!
Compare the numbers... blarcamesine is nearly 3x better and much safer.
Yep... we're dealing with the same team of paid FUDsters and collusive cabal as last year.
WRONG! A safe drug that is demonstrating efficacy WILL BE APPROVED for Rett.