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public traded or not lying NWBO trial failed at a conference like that is a criminal offense by many standards. What I think happened is that this CEO wants to raise money by pretending other trials have failed and their is the one to put money into.
This CEO can look out for some serious problems lying to investors, lying about DCVAXL...
the FDA requires that the Sponsor gives the TLD to the FDA first, before it is released to the general public.
In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
Source: https://www.law.cornell.edu/cfr/text/42/11.44#b_1
why could there not be an approval, which it seems they are going after before the publication can appear and after then after that a BO?
In any case, we all have to now come to grasp that is going to still take much longer probably months.
Looks Judge Snails is right and this will be after the summer
I know some here believe that the UK (MHRA) will be the first to approve DCVax-L. I would not prefer this, but I would not be mad or disappointed if it happened this way.
excellent post
now you are turning it into another delay the discussion was waiting for RWE and I responded to the RWE before TLD.
Ok new subject "another delay out of nowhere"
another delay in comparison to what?
A. to there in coming months statement 1 year ago: agreed check
B. To the average or median time after data lock to a journal publication: agreed check
C. to new timelines provided by NWBO: there has been none after March 2021: so disagree
Yes, there is a tremendous and IMO like I said yesterday for patients outrageous selfish delay.
There is however nothing I can do to change that
It would not surprise anyone if that turned out to be their strategy though.
well I am not sure what some posters are referring to pgsd seems to suggest NWBO is waiting for RWE first to have the article published after?
In my view, it would not even be necessary for NWBO to wait for RWE before submitting BLA or FDA RTOR
it would be more prudent to wait with submitting BLA until after RWE has been in place. The journal would not care much with this FDA guidance since the Lancet article so I cant imagine that being the hold up. All IMO
If they are waiting for new FDA guidelines being implemented then we have to wait for any new comments to come in first
https://www.foley.com/en/insights/publications/2021/12/fda-draft-guidance-real-data-evidence-regulatory
FDA recommends that stakeholders submit any comments on the Draft Guidance by March 8, 2022 through this docket.
I don’t feel like doing any more work than this.
However, many drugmakers announce when they receive a PDUFA date from the agency for one of their drugs. Such announcements can be major catalysts, especially for small pharmaceutical, vaccine, or biotech stocks.
Often companies have the final draft label minus minor grammatical tweaks well ahead of receiving the approval letter. They already know the answer but it isn’t official and they can’t and don’t leak this information. They can line up contracts and all thing necessary to launch. They can even print material “at risk.” How else do you think product can be available on Monday after receiving the letter on Friday?
Submission to RTOR does not include a prerequisite of TLD publication announcement.
they are possibly waiting for the new regulatory guidelines to be implemented swiftly followed by the clinical trail site update with new endpoints and release of TLD/publication.
Yes lives might be lost in a few cases
if NWBO has submitted data to any RA in whatever pathway FDA RTOR or else, then that would mean NWBO, as far as I could research, would be FDAs first (and probably EMA as well) biotech submitting data to the FDA without disclosing topline first.
Well, one biotech has to be the first right?
no panic,
the whole market is down incl NWBO. There is a big head and shoulders forming on the SP500 that could bring us back -10% to 3390
yes I agree with that but that's behind us now is it not?
also prior to the certification patients were able to get treatment right.
selling even one expensive DCVAXL treatment from this day on forward while knowing the data but not disclosing is IMO immoral
Im sorry I was a bit emotional because of that boy in our neighborhood (my son is around that same age, he did not know him personally)'
If their claims were handed over to another authority to investigate widespread corruption and that case is being investigated in an ongoing manner and multiple levels of government investigation are going on how does that work?
its absurd.
What about patients that could have been saved by announcing TLD + a less prestigious paper explaining the data months ago? I know via, via of a 16-year-old boy who died of GBM 2 weeks ago (I do not know the family personally). If that family would have had assurance DCVAX L works and had gotten the go-ahead from their MD because of disclosed TLD and the explanation of the data in a smaller paper. They could have sold their property and perhaps saved their son. Or start crowdfunding and get the finances by telling people this treatment really works.
I personally think it's outrageous to have desperate patients resort to or doubt going to NWBO/Advent for treatment without their MD being able to give a go-ahead, no data no go ahead. Imagine being a patient not knowing whether it's wise to put your last money in DCVAX L because your MD can not give a go-ahead because the data is unknown yet.
This is ALL because the egos at NWBO headquarters dont see the urgency and want a prestigious journal to publish.
outrageous..
Doc logic I have trouble trying to understand what you are saying.
The limitation period of an unlawful act is, in general, 6 years which means that NWBO can no longer claim suffered damages for stock manipulation, if any can be proven which I highly doubt, with parties involved in the manipulation, prior to Feb 14 2016 as of today unless NWBO has already claimed and substantiated damages with certain parties within the 6-year timeframe, which I also doubt.
Documenting any stock manipulation wrongdoing won't change that, it only confirms NWBO is and was aware of the wrongdoing which complicates a request to extend the 6-year time frame.
best wishes
yup could very well be possible. Nothing is off the table when it comes to NWBO and timelines. But I won't be around to see that happening if no TLD by then.
I understand.
Like I said before at this point for me TLD+journal is not good enough anymore they better come up with the announcement of BLA submitted and or the approval by the MHRA or I will write a serious complaint of them having waisted so much time lol
I understand. I will probably sell completely 2 weeks prior to ASM in anticipation of news if of course no TLD by then.
PM will you sell if no TLD on March 1?
I hope not hope, I hope you stick around, but I understand if you would
that makes a lot of sense I agree
provided the results are good IMO yes
will certainly be able to claim that they never had sufficient resources
Im not going to lie I think the delay of TLD + publication is beyond absurd as well.
They better come with more than the article alone cause that is now just not good enough anymore.
Yes I know I was there ;) lol
But I now get what you meant
Et tu Brute?
Odd that supposedly NWBO never submitted a SAP until way late
If the plaintiff can demonstrate they had no or could not have prior knowledge about the foul play (for reasons of covering it up) by the third party then that is correct.
However, if even this board had knowledge about stock manipulation then how can NWBO maintain they just did know. I think any claim of liability for stock manipulation is going to be extremely difficult for NWBO after all this time has passed. They just should not have waited this long IF we will ever see any such claim for suffered damages by NWBO which I highly doubt tbh.
well then they better hurry the hell up since the limitation period of an unlawful act such as stock manipulation is generally six years. The limitation period starts running from the date of the breach occurs or the tort is committed.
In fact, I think they may already be too late if they have not filed any liability with any third party yet.
But wait... speed and continuous urgency is one of LP specialties. lol
It really does not take that much time. Major journals require a 2-3 week turn around from reviewers. A reviewer can say they cannot do it on time. They just get someone else. A major revision should take at most a month unless something is so bad it requires going back and doing more work. Months delay---no.
I am convinced the article is in peer review and the delay is due to obstacles in the peer-reviewing process
the mother of all news will ofcourse be TLD + publication not only because the approval will indicate future revenue but foremost the speculation of an acquiring of NWBO against a much higher SP (and an uplist before that) can then begin.
Does telling someone that your paper has been submitted considered fall under this criteria ?. I really doubt that surely discussing the data is unethical but telling someone that you submitted your paper without leaking any data remains ethical.
Thank you. That I knew already and now in peer review (As DI told us) with delay in the peer reviewing unfortunately. Hopefully sorted out soon
Lol that’s what always happens. Im long in anavex a tiny bit and I believe the big gain is still ahead of the stock. Im planning to increase my position after NWBO TLD but probably then the stockp will be x2 what it is now. If anavex will get approved for Alzheimer’s boy oh boy that would mean a MC of 25 billion at least