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Scenario 1 1. We know that the conference presentation was never meant to be held prior to TLD + Publication so during the quiet time. => Bosch must have been receiving many emails from the conference months prior and right up till the conference. So the conference and his responsibility for his attendance must have been on his mind all that time. Therefore if he knew weeks before the start of the conference that TLD + Publication would take a long time he would have canceled weeks before.
2. On Monday, January 10 MB was made aware by either email or a phone call from the event manager that his time of appearance had been shifted for Jan 20 from 11..40 to 12.10.
Please contact your Event Manager or Program Director for more information. Please note that all times and dates are subject to changes, so please be aware of any updates that may be communicated from your Program Director
=> So if MB already knew on Monday 10th that he could not attend he would have canceled that same day as he was made aware of the rescheduling.
3. On Thursday, Jan 13th MB canceled.
What is the deadline to provide for my presentation All presentations are required a week before the meeting. Reminders and deadlines will be sent to you by email by your Event Manager and Program Director
So he canceled last minute which is confirmed by an email I received from the conference:
In response to your enquiry, I’m sorry to confirm but Marnix Bosch will no longer be presenting at this year’s event. I apologise, he has had to drop out last minute. Kind regards, Kiran Thomson
=> Since its clear they waited at the last minute to cancel and this is in relation to pending TLD + publication in my view they anticipated TLD even as far as 1 or 2 days before the deadline on 13th. As I said if not why not cancel on Monday 10th when MB was made aware of the timetable reschedule or weeks before that when receiving emails about the upcoming conference...
If they expected TLD + publication just before the deadline 13th then in my view TLD + publication will not take long anymore.
Scenario 2 4. Alternative explanation MB knew (many) weeks before the conference started he would not be able to make it for he knew a lot of work still needed to be done for the publication. He just could not care less about the problems he would cause for the conference organization canceling last minute, even though he was made aware of his pending presence by different emails over a long period of time until right up the deadline 13th, and thus he canceled last minute when the conference called him to ask him to asap submit his presentation. I do not believe that to be true at all.
One thing Im convinced about the conference was supposed to be after results had been disclosed. There is just no way NWBO will present anything in their quiet period. I think it was kinda not on MB's radar when he got the email Thursday, got reminded, and canceled.
MB is definitely a co-author as he was in May 2018.
That to me indicates and I'm speculation now I realize that, that they still have not a definite publication date. Could be peer-reviewing which I suspect could be the last details.. we don't know where they are .
when am I speaking Please contact your Event Manager or Program Director for more information. Please note that all times and dates are subject to changes, so please be aware of any updates that may be communicated from your Program Director
Looks like it was not MB changed time
What is the deadline to provide for my presentation All presentations are required a week before the meeting. Reminders and deadlines will be sent to you by email by your Event Manager and Program Director
Looks like when MB received a reminder to provide his presentation on Thursday he bailed.
So taking Dr. Bosch out of the conference in order to get this to the finish line, would almost certainly mean they need him working on finishing up the Journal preparation (Aka: back and forth editing), imo.
if thats the case then that also could very well mean there is still a back and forth with the journal aka peer review stadium and that could mean we are still many weeks away from the publication it also means they have or had more hurdles to overcome the anticipated.
I hope I'm wrong. I have heard different but NWBO isn't good with timelines and gets surprised by NWBO as well.
at what point will NWBO get a name for constantly pulling out of conferences? Seriously. This must be a huge nuisance to the glioblastoma-drugdevelopment conference organization they pulled out 4 days before it started, people are paying admittance.
ooh yeah, it happens that people forget its the other way around. The same for crypto as in Casinos always place your money on the color or number where the ball will fall on next, people seem to forget that simple rule lol
Are you really saying the FDA regulates the ability for NWBO to sell DCVax-L in the UK?
wow it amazes me that you did not know this but NWBO is an American corporation regulated by the American FDA first and foremost
For pharmaceutical companies operating in the United States, the U.S. Food and Drug Administration (FDA) regulates the drug approval process and oversees the expanded access pathway for patients with an unmet medical need to access investigational drugs under 21CFR 312 Subpart 1.
and of course, like I said they need the MHRA to approve the compassionate sales as well
However, pharma companies seeking access to the European market face dealing with the European Medicines Agency (EMA) for drug approvals, as well as navigating a myriad of country-specific regulations on accessing investigational drugs.
Do you really think that the FDA after seeing the ineffective DCVAXL data really would not step in while NWBO steps up production selling DCVAX L in the UK? Do you really think the relation between the US and the UK is that bad the FDA would let its British colleagues in the dark?
And do you really think the MHRA would let a situation exist where an American company can keep selling a high-impact biological drug with life-threatening consequences in the UK without any knowledge of the opinion of its counterpart the FDA?
The UK, not banana island you know.
Wow you are either incredibly naive or really, really dont want patients to benift.
NWBO needs continuous FDA permission to sell DCVAX L as compassionate treatment, which we know for a few days now is exactly what they are doing, has just started up, in Sawston. FDA has seen the data for sure, combine the two and you know what time it is.
Moreover, the FDA and the MHRA have permitted the continuation of the compassionate sales of DCVAX L in Sawston after the FDA has become aware of the unblinded data. It would be beyond bizarre if in the near future the FDA would turn around and disapprove DCVAXL after the BLA is submitted.
It's my impression that when the first Dc Vax L vaccine is made at Sawston, that event will be considered by nwbo's DC law firm to be a material event.Then it will be 8-K ed and maybe PRed
I dont think thats a material event. NWBO has outsourced the production DCVAX L vaccine more than once so I see no reason why the outsourcing of a DCVAX L vaccine to Advent is material.
Is the production of a DCVAX L vaccine at Sawston something which an average prudent NWBO investor would want to be informed about? Sure but at this point, NWBO investors are so thirsty for any information that given that Supreme Court definition what LP had for lunch is material.
Basically he got a vague response that could have been used a year ago as easily as now. It could cover just about any more specific reason and so tells us next to nothing, which is par for the course.
This I agree with you. If NEJM has moved the timeline a few weeks (for example) he could not have said that
Your explanation makes sense. If the presentation was always intended prior to TLD / journal as we have seen Dr Liau's last year then they would have not canceled. Something very short notice came up so they had to cancel and if I had to guess it is NEJM letting NWBO know they had to move the publication to another time frame.
You have to give Bosch a bit more credit then that he would not have confounded the trial results, he is NWBOs CTO and co author!
Let’s say they planned max 2 weeks between TLD and the journal and Bosch just after TLD. It would not surprise me if NEJM called them yesterday and told them they have to move the publication to half feb. In that case it would leave them no choice to cancel Bosch. If the publication were not ready yet then they would have known that weeks ago and cancelled a lot sooner. IMO
To me, that would be more of a bullish sign, i.e. they waited till last minute to pull out because they thought TLD/pub might happen.
Like I said they changed the timeslot on the 10th from 11.40 to 12.10 for Jan 20, so on the 10th they still planned to attend. What changed their minds in 4 days' time?
haven't been around prior, but in the past when the pulled out of a conference how much notice did they usually give?
I dont know but what is strange is that on Jan 10th Bosch timeslot on Jan 20th was changed from 11.40 to 12.10. Apparently on Jan 10, freaking 4 days ago, they were still planning to attend so what the hell happened in 4 days' time that changed their minds?
One thing we can be sure of is the FDA has seen trial data and if they did not like the data they would have stopped/warned NWBO from proceeding with the compassionate treatment as what they are doing now, full steam ahead.
What signal would the FDA, UK/EMA give if they later this year would dismiss DCVAX L to patients that have been treated.
Unless you need that money soon, there are other options to consider like contacting one of those law firms that have investigated NWBO or filing a regulatory complaint about the failure to release TLD within 12 months of data lock. The law firm could always announce they are investigating the issue and that might shake the information tree.
This argument would be laughed out of court for one reason in particular - COVID
Such lawsuits would be dismissed because legally a shareholder needs to first summon the NIH to summon NWBO to uphold that rule and if the NIH does not adhere you could try to sue the NIH to summon NWBO.
But I am 100% sure NIHs rebuttal will be that NWBO did not update the clinical website with the trial completion date so the NIH officially has no knowledge of NWBO's completion date or if there is any. Therefore anyone must first summon the NIH to summon NWBO to update its clinical website with the completion date.
Also I'm 100% sure NWBO did NOT request an extension of the 1-year deadline for any reason, COVID or not, for if they would ask the NIH for an extension the NIH would reply that NBO first has to update the clinical website with the study completion date before they can request an extension. Since the 1 year after the study completion date has long passed that ship has sailed.
I think they may have had pre-BLA meeting(s) late last year and would be close to submitting their final BLA this quarter closely on the heels on TLD+publication
many have asked you questions that you have left unanswered so Im a bit reluctant to answer your question for that reason. But ok.
There are certain circles that have proven to be very reliable to me even more so than LG. And that is because LG has not been that reliable over the years. So firsthand info does not need to be super reliable perse.
But my sources are the second of your equation and your conclusion that such is thus less trustworthy is not my experience.
I think the delay of results is due to the delay of the publication which is in turn due to covid. I have heard (reliable outside this board) its very very close (publication).
Since the publication is not in the hands of NWBO it would be a complete waste of time if meanwhile, NWBO had not worked on BLA and expedited approval but in what phase that is I have no idea.
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thanks dec 2016 how time flies
