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<<< Assuming there is an RFI they could easily delay. >>>
100%!
But that would be a material event that needs to be PRd. IMO
Could be 60 business days,... X 2 with an extension.... , then another 70 business days for the rest of the assessment if all that goes well!. Could go well into the Fall .. IF, they get past phase ONE! Which is not a given at this point. All while they are bleeding cash and diluting the stock almost daily.
I don't make the rules, I'm just following official guidelines from MHRA... AND the Company's own press release! Apparently I am the ONLY ONE
Where are these "bashers", ???? Please show me and I will straighten them out with empirical facts....
#Materialevent. It amazes me how people just do not read, or cannot read!
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
For the GBM MAA, the Company anticipates that the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority as well as preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information.
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-marketing-authorization-143000107.html
From MHRA, I meant ....not the company
We will soon find out
If you are allergic to facts, then yes...
I believe there is a phone # for IR at the end of all the press releases, maybe you should call that # and ask for yourself,... perhaps?
And define it perfectly, right down to each individual!
If they don't get outright REJECTED first...
Are you still around?
WOW, that was a great read.. Magnificent post!
Would love to correspond with him... Is he still around?
The 80 business day phase 1 stage , I believe, will be released by MHRA to the public... No need to rely on the scoundrels for that one... IMO
Apparently they can request an extension, ( only granted for exceptions) which they probably will, but it is not automatic that they will get one.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
Like Nature articles, NIH website, and MHRA guidance? That kind of false info?
LOL. you people are hilarious.
Please show evidence... Dummy! A simple call to LG, the legal Rep., would confirm my statement... Just sayin'
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
Maybe you should call Les Goldman and ask him?
PS... If Holidays and weekends are included, where is the 80 day assessment? Dummy
Who picked 2:30?
POOL
What time will it break 50 cents...? Make your predictions.
Go
Your stock is going to zero...
JMO
GL
I'll put my opinions up against the idiots who own this scam stock, any day of the week!!!
Can you read? PS, no apostrophe needed in "yours"
IMHO, of course
2 idiots for the price of one
Apparently,... you've learned nothing in all those 30 years. Are you even 30 years old? 🤣
Where do you see that? LOL
This is a Glen Miller stock...
Love the 40s....
Maybe Charlie Chaplin?
20s... silent movie era.
<<< However, I do believe that approval is 95% and approval could come within the next 30 days. >>>
Umm, the app hasn't even been officially accepted yet and the RFI stage ( if accepted) hasn't begun yet.. WTH are you even saying? Get ready for $0.40s or maybe $0.30s....
RIF... Reading is Fundamental.... LOL
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
The 80 bus. day phase 1 ends this week! We will soon know if it was accepted and ( if accepted) when the RFI phase begins... It's either curtains this week, or a long process until final approval occurs.. "60 day clock off" with a possible extension and then another 70 business days AFTER THAT for MHRA to consider a potential approval.
Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
You mean the early stage trial that NWBO is NOT a sponsor of and has absolutely nothing to do with the data up for approval with MHRA? The one where UCLA owns the license for?
That one?
Where is the PIP trial?
I'll wait.
I have seen hundreds of these scenarios.. Most end up at $0.0005
It's been long enough for all to see the DCVAX results, nobody cares, nobody wants it, the street hates the mgmt,, for good reason.
LP absconded with Cognate and now Advent, and the trial was flawed, at best! Corrupt at worst.
20 employees, no structure or communication with shareholders, lots of trickery and social media promotion all rolled up into a death spiral for the share price and ultimate demise of the entity. Best case is a fire sale for some of the patents that haven't expired in a BK sale. Advent will most likely be the buyer.
Again, all my opinions
JMHO
<<< (the pan was approved Aug 2022). >>>
And the trials have not even begun! Where is the $50 to $100 Million gonna come from?
<<< It should be obvious why a private Advent competitor might want to buy a real stake in public NWBO, especially if the geniuses here really believe that NWBO is a diamond in the rough >>>>
"Contradictions do not exist. Whenever you think you are facing a contradiction, check your premises. You will find that one of them is wrong."
~ Ayn Rand
DCVAX does not work, nobody wants it except gullible retail stooges who believe fantastical hype posts by anonymous paid pumpers. In my opinion, and the opinion of just about every single institution!
Institutional Shares (Long) 533,820 - 0.04% (ex 13D/G) - change of -2.57MM shares -82.82% MRQ
https://fintel.io/so/us/nwbo
Advent is not putting a penny into NWBO, they manufacture for multiple other companies and will likely be sold for over $1 Billion. Owned solely by LP and Toucan.
NWBO is likely going to be ZERO soon... IMO
I'm starting to think that most people on this board are mentally and intellectually challenged.
And please check your spelling before posting
not... a... chance....
You must have been absent when they taught continents...
WTF does that even mean?
10 cents
The only "buyout " will be by Advent at 2-3 cents per share, if that much...
wow, .... you are in for a major disappointment. IMO
JAMA . DOES. NOT. APPROVE. DRUGS. !!!
JAMA . DOES. NOT. APPROVE. DRUGS. !!!
JAMA . DOES. NOT. APPROVE. DRUGS. !!!
It is therefore disappointing that due to key methodological limitations, the DCVax-L trial ultimately failed to provide sound conclusions about the potential efficacy of such approach for patients with glioblastoma.
https://pubmed.ncbi.nlm.nih.gov/37012085/
Dear Clueless;
Um, JAMA does not approve drugs...
Sorry for your loss
It is therefore disappointing that due to key methodological limitations, the DCVax-L trial ultimately failed to provide sound conclusions about the potential efficacy of such approach for patients with glioblastoma.