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We will find out soon after approval .
I sure hope that management has lined up a good deal with large upfront cash to be announced with the approval if they think they deserve the shares awarded to themselves .
Not only that of some one raises concerns about execution and handling of things that usual group starts bad mouthing that person and starts calling that person paid basher and short . It’s quite amazing really
I am not denying the fact that it is safest among all other medicines/modalities being used for GBM.
Point was that , was it used in addition to current SOC in the P3 trial or not ?
To clarify above statement : if patients were crossing over , doesn’t that mean they got both treatments ??
Yep they conveniently keep forgetting that it is in addition to current SOC
Not trying create any negativity , but the MIA human designation is for U.K. , it has nothing to do with US trial sites as far as I understand . So how can one say with 100% certainty that they can’t request more information for these sites , if that’s actually the inspection is for ?
I don’t know the answer .
Agree
If they received regular RFI they likely addressed it before inspections
As I answered to Doc that getting human MIA designation should also minimize and major information request even during inspections .
Although I am still not clear about inspections scheduled in US , are they inspections of the trial sites ?
I think that’s a reasonable assumption
“
The board here is about this company, and this drug and its science. In response to your last point, if you don’t want to discuss those issues, you don’t have to post here. There are plenty of other places to post not about those things. But that is why the rest of us are here…apparently you can’t answer without being beat, and that annoys you. Don’t make dumb points.
“
Being critical of company’s and its officer’s execution is “about this company” genius . But in your alternate universe only singing praises of company in a choir or apologizing for them “ is about this company”
As I said the posters who want ROI and accountability got my post .
lol
Sure
The posters here who don’t live in alternate universe and are not perpetual apologists , got what I wrote .
But you carry on with your “occasional” pop ups
Can’t make it up
But you are saying that you know for certain - 100% , that there was no RFI?
I am sure Sky will never run this post through this chatGPT BS and sever other’s that everyone know of .
Yep there are some here who live in alternate universe in their minds . Hard to reason with them .
Yep we are on fast track . A very fast one .
.30 seems to be transitioning from support to resistance , if it stays below .30 for a day or two more .
No one can know one way or other unless company or MHRA make an official statement . ( not on individual phone call)
Umm lot of us critical of company’s execution have disclosed all along our long position which apologists and cultists like you ignore . All the reasonable posters here have seen the veracity of your predictions and explanations . So I don’t need long winded posts to explain which is very obvious to most reasonable posters who have read your tirades over the years . And they have also seen your rabid antagonism of any differing opinion or any criticism of company with unsolicited worthless lecturing about science or investment .
Non sense
Every one can see that you “pop” occasionally these days
Enough said
Someone who is here 24/7 trying to defend and apologize for company , by replying to every possible post if needed to do so , even if comment or question is not addressed to him , is calling others desperate .
Everyone sensible reading the board over last few years can clearly see the obvious . But do carry on , you have to do your job .
Lol
Sure genius
Without news it is headed there u fortunately
No worries Doc
My post was in response to a general assertion that if there are inspections scheduled that means no RFI can happen after that , and that is operating procedure of MHRA . I was trying to make a point that RFI’s can happen even during or after inspections if questions arise . It was more in regards to general operation of MHRA.
I do have a question for you though . Per some statement , if I remember right Inspections were going to be scheduled in U.K. and US ? The human MIA designation is for U.K. if I understand it correctly . So what are US inspections for , to grant U.K. approval. Are these inspections of trial sites? And if so then how does that makes the risk of any RFI zero ?
Thanks in advance
I did post the question in response to Captain obvious’s post and it was pretty simple worded question
And I agree ChatGPT is not the best or most credible of sources and I have said that here as well and I was actually posting those chat GPT replies in response to some who post chatGPT answers if they align with their belief . I actually posted here that for similar question approximately 2 weeks apart , I got much more optimistic reply from chatGPT regarding timeline between inspection to approval . It was a reply to Flipper . You can look through those posts.
I really hope that they have some good deal with large upfront cash lined up with approval. That’s the only way in my opinion SP will appreciate and they can uplist to realize the true value .
Also I think if all the information ( if RFI had been requested) has been timely provided by NWBO to MHRA, there is not much company can do or say from U.K. approval standpoint . Then blame for the delay is completely on MHRA taking longer than their unclear timelines / guidelines .
Not sure they can .
During ASM they clearly said that they won’t be giving interim update about MHRA process .
I think it’s MHRA’s inefficiency , seen on the performance metrics on their website, that is responsible for U.K. approval delay .
Some of us want more global updates like status of application to the markets which are actually lot more important revenue wise , delay in submission of NICE evidence , plan to uplist , other business plans for cash reserve ( non dilutive) to fund operations and trials etc etc and of course advent .
But I am sure usual few here will reply with answers , which we all know very well what those will be , that none of us care for . Some of us would prefer updates from the company in black and white and documented and not to individuals on phone calls with no records .
I also believe that U.K. approval should come this year . But looking at new drug approval metrics from MHRA website , I won’t be surprised either if they push it to next year also .
It’s quite typical when he and his buddies get cornered , they start crying paid bashers .
Hi Doc
I never said that Human MIa designation was not a very positive development
I posted verbatim what chatGPT generated , in response to the chain of posts , discussing the scenario that since inspection has happened , there is zero chance of RFI
You are being disingenuous
by commenting on that post without context of the discussion that was going on.
Take it up with chatGPT that every one so loves here when they like the answer
My post is verbatim what chatGPT generated .
Lol
He doesn’t like to be shown facts . Just fall in line and have blind faith
he is just pissed that he has not been able to order his yacht that he designed 5 years ago . He has to blame someone for it .
“ NWBio has not submitted their DCVax-L BLA / MAA to the FDA, Health Canada or the EMA yet.”
Approaching half a decade since data lock
And hence the SP
That’s is called plausible deniability . If your milestones are not reached for a decade , you can say for whole decade that you were not wrong
I know , he probably had few meetings with designers for his new luxury yacht few years ago
Agree
It will have to go to a regular exchange to reach $5 .
Lol
What’s going on is that people are not getting sucked into hyperboles from usual apologists and blind followers like you and have gotten reasonable and demanding accountability from executives just like any executive of any other public company who has used money from public , and expecting ROI and concrete plans for monetization and revenue after more than a decade long wait.
I know it is a foreign concept for likes of you , and it possibly is painful to hear the voices of reason instead of listening to yourself in an echo chamber you would rather prefer here .
Lol
I don’t need to deceive anyone .
Look at the SP
Cool
I believe in our case it is still several months to a year away
You should also give them 25% of your shares back for free to your appreciation and reward them