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LOL... the FUD seagull arrives on cue.
Boldface FUD lie...
Weren't you paying attention when Missling clearly stated that Rett results will be provided in this half? And his intent is to surprise the cabal... err market.
FYI, it'll be this half until 12/31, but I'm confident the surprise will come well before then.
Your posts are absolute FUD BS!
Other points of emphasis...
Unfortunately, there's no cure for what you suffer.
If Missling didn't believe that an approval pathway is forthcoming, he wouldn't be talking commercialization nor would he mention the possibility of the AD OLE serving as the confirmatory trial. He likely has had conversations with the FDA about it for him to make such a statement.
I've been an investor/trader here for over 8 years... and have experienced all the nonsense FUDing and short attacks on excellent news/results.
We know who the cabal soldiers are...
Again, the company has stated that all endpoints were met. Mean score is not the only method of measuring efficacy and trial success. However, do you really believe that an Odds Ratio (ADL) of 2.67, where >4x of treated patients over placebo patients exceeded a specified level of improvement, wouldn't have a statistically significant mean score comparison? Hard to imagine, isn't it? However, not exposing it has sure created a lot of FUD.
LOL... tactics of a paid FUDster... trying to turn it around. Quite hilarious...
I agree...
Ya know, ya can't let FUD get the upper hand. You're welcome!
Hey, tooshort, WGT! Approval next year!
(We suspect that you're actually a paid basher who likely holds a very small position.)
FYI: The endpoints will be what Anavex and the FDA have agreed to as noted on clinicaltrials.gov. The prognostication about it is rather comical.
Doesn't it feel like a couple of "soldiers" (i.e. FUDspects) pontificating what the endpoints should be, as well as the related data, perhaps to start developing their next attack strategy of how the Excellence TLR doesn't "measure up"! Can't ya just sense it coming?
...and many have seen your work at creating FUD.
I can clearly differentiate between well reasoned analysis and that of contrived FUD.
Yours is of the latter. The tactic of flawed inferences has always been your style.
Funny how it's only the cabal soldiers who try to deny their own existence.
These people are paid to post despicable twisted narratives of FUD for their handlers (HFs/MMs) who collude to manipulate prices. They have no conscience or compassion for suffering patients and their families... they're heartless.
To them it's all about serving their bosses and the Almighty $.
Simple... when signals of efficacy aren't all that evident, as with Leqembi, then another P3 (confirmatory) is typically required.
However, when signals of efficacy are quite clear, as in meeting all endpoints with super responders, then the trial becomes pivotal (P3). An approval pathway is established and the confirmatory trial is an open-label, placebo-less "P4".
As indicated by Missling, the current OLE, which completes next July, may very well serve as the confirmatory trial.
But you know all of this... you just choose to deflect and distort to spin your FUD narrative.
Indeed... it would be funny if it weren't so despicable
The only spin we see here is by you and your colleague cabal soldiers... i.e. FUDsters.
Your nonsense spin that "very little has come to fruition" is just another FUD lie.
Every trial has been successful and we're about to see another successful trial with Excellence, that will lead to approval, along with AD, next year.
More than half in the OLE have already completed the trial. That data will be included in the NDA filing. If the FDA accepts the OLE as the confirmatory AD trial, the remaining patients will complete by next July. Expect AD approval soon thereafter, with the aid of the PR voucher, on the heels of Rett approval.
If Missling were viewing the AD trial only as a P2b, then he wouldn't be positioning the OLE as a potential confirmatory trial with the FDA.
Do you not listen to what Missling states... or do you just summarily dismiss and discount everything he says in typical FUDster fashion?
Missling clearly stated that Rett results will be released in H2 of this year.
My expectations for NDA filing by end of year is much more realistic than Investor's baseless statement that there will be another PM P3 AD trial.
With another biotech, it took just 6 months from P3 TLD to journal publication, reviewed by more than 50 doctors.
Anavex is approaching 9 months.
Oh, it's happening... stay tuned.
It's the reason for the collusive manipulation and FUD speak.
The company believes it has provided adequate evidence to support the "Met All Endpoints" claim for the AD trial... concocted FUD narrative notwithstanding. Thus, there is no urgency to release additional data (subgroup analysis, biomarkers, MRI data, sleep studies, etc.) until it is all completed and analyzed. The other possibility affecting the release is a potential data embargo imposed by the selected journal, which keeps the details under wraps until the journal is published. I fully expect the journal to be published this year (Q4), which is independent of NDA prep and filings.
The next bit of data will likely be the Rett Excellence trial TLR. Although, a surprise release of detailed AD data would be most welcome, it's not expected before the journal publication.
You'll soon see that your soft bashing will be proven wrong, when the peer-review article includes PDD, along with AD results/data. NDA filings for both Rett and AD will follow and the AD OLE will become the confirmatory trial. Rett approval expected mid next year, with AD approval soon thereafter.
Such FUD BS postings for a few Judas coins.
The AD NDA is likely complete, waiting for Rett results and filing later this year. Expect approvals for both Rett and AD next year, along with partnerships and commercialization.
Better start covering your shorts.
Sorry... but that is a baseless accusation, likely to be proven false.
It's the factual data of the AD trial that conclude an astonishingly positive outcome, where patients have functionally IMPROVED!
It's rather dubious how FUDsters continue to neglect and discount the successful results... Don't you, Dr. FUD?
LOL... We all know that the pump up to $30, based on successful trial results, was helped by the same collusive manipulators that brought the price back down again. It's one and the same organized HF/MM cabal... you know, your handlers.
Nice try... The many successful trials weren't the reason for the stock price retrace from $30. We know and you know it is collusive manipulation... and it'll continue until approvals come next year.
Your FUD is wearing thin!
The history of the company is one successful trial after the next! They are working on NDA filings, partnerships and preparing for WW commercialization.
More baseless nonsensical FUD from you. It's rather pathetic.
Folks... this is nothing but organized collusive manipulation. You can tell by all the FUD that the usual characters start spewing in concert with the manipulated takedown. This is what they do before news comes... shake the tree hard to run stop-loss orders and get retail to sell.
They know their time is running out. This will recover, and then some, within a week or two.
Frequent wash trading of 50k sharers between HFT computers can give the illusion of volume.
I clearly stated that the runup was pure manipulation... as a setup for AF's timely pre-written hit piece. Textbook collusive cabal manipulation to bring it all the way back down.
Pocketing $1.00-1.70/share on a reload is never a bad thing. Tell your handlers 'thanks' for me, especially AF for the tipoff.