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Its profit taking we have been at sales prices for a very long time this will be a runner coming weeks
all messages from Les are good news by ddefault, doesn't necessarily mean they reflect reality lol
when NWBO was referring to Covid delays perhaps, as we all assumed, they were not so much talking about the delays they experienced internally experienced as in getting for example getting the publication-ready. But they were referring to FDA delays who due to the Covid crisis had a huge workload and thus had little time for cancer treatment approval/BLA/data submission/SAP etc filings...?
if there was a trial design failure, as what ex asserts, then we would have already learned that by now. There is none. The SAP has been bought in by the FDA they did not hear anything back. All we need to know now is if the data is good, which we know it is.
I dont think they will just release data I am by now convinced they will announce approval UK or perhaps even FDA at the same time, that's why it is taking longer
Thats what I think
Other than Linda Powers herself stating that they have submitted the SAP (which btw is not amended or updated as you state but their first and ONLY SAP as clearly proven by Senti) to the 4 RA's and other than being able to read from EMAs website and other than the EMA have stated that they bought in the endpoints of the SAP as you can find on EMA website and other than LL saying that EMA/Uk/Canada is a smoother process and other than repeated statements by NWBO thats all the same SAP
other than that we longs are clueless.
How is that going?
yes and extreme absurdism
I seriously was laughing for a full minute reading your well whatever it was.
so let me summarize what you are saying and Im chuckling again.
Dr Liau confirmed yesterday that DCVAX L has told NWBO recently that DCVAX L is safe? hahahahaha thank you FDA for that info now we can euh start Phase 3 trial hahahahaha ? Come on man who takes this seriously. In case you have not noticed but NWBO has ended Phase 3... and is not about to start a DCVAX L Phase 3 trial. So why on God's green earth do you keep saying that the FDA wants to make some remark about safety or NWBO wants to hear that from the FDA post hoc the trial? Perhaps you dont know but safety was already established many years ago in Phase 2, Phase 3 could not have started without understand?.
Its like NASA officially letting a returned astronaut know that he has nothing to worry about since his flight 8 years ago is safe. hahaha
Ooh and if Dr Liau was talking about SAP then she violated SEC rules? Please let me know which one Im all ears.
lol
ex arent you happy NWBOs SAP buy-in by the FDA has now finally been resolved?
the FDA is very adamant in letting a biotech know straight away if an SAP does not meet the required standard. They will not let a biotech especially a small one swim in oblivion submitting a BLA with all the intense hard work that is needed drafting a BLA knowing all that time they will reject the BLA because of a disapproved SAP. Moreover, they will support smaller biotechs.
This is exactly what happened with Anavex. They were corrected and supported by the FDA in their effort to get their SAP correct.
If the SAP was no good NWBO would have been notified and we would have already been informed by NWBO as that is a material event.
This all looks very very positive!
although we have not always been on the same page ...
I 100% agree with your post here
thanks I agree the past is the past and we move on now we longs all want this to succeed
and thanks for your timeline estimate. It's incredibly reasonable to assume NWBO is waiting for RTOR feedback. That would be a tremendous boost for the SP and the program
wow so they are not only lying to investors about NWBO trial results on April 9, 2021 when NWBO was probably not even unblinded or just unblinded, with very specific data but also misleading investors about their own trial?
Has no one learned anything from the Elizabeth Holmes lawsuit?
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...
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
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
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
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)'
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