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REVENUES:
Research and other $1,932,000.00
NET LOSS
Net (loss) income attributable to common stockholders $(64,373,000.00)
I don't know and I don't know if all of that $1.9 is from vaccine treatments..
You can look at the 10K
$1.9 million in total revenues for all of 2023, so there cant be much of anything there
Maybe because it's true?????
Wow what a concept,... truth !
That's why no FDA, no legit exchange, no Pharma partner and no chance of approval... IMO
<<< I have tried to manage Asian workforces in a prior life >>>
LOLOLOLOLOL. You people are hilarious. Was that before or after you survived cancer 6 times by getting DCVAX on the black market via go fund me ? You forgot to say " cemented". lol
This board is better than late night comics!
Dude, the stock is going to $0.0005 in my opinion by 2025
Just my opinion, do what you want
89% held by institutions... No explaining, dancing around facts, or BS necessary. Just results that the FDA liked...
https://finance.yahoo.com/quote/DAWN/holders
And that's why they applied to FDA and stayed on NASDAQ? NOT.
LOL
You bought stock in a snake oil company. Sorry
As usual , my opinions based on thorough due diligence.
NWBO just basically made everything up after the trial failed. Changed protocol and end points and added a bogus external control group, 4 years after the failed trial.
That's my take on things, backed up by peer reviews publications on NIH website
<<< You just admitted the OS results in the DCVax-L P3 trial was terrific. >>>
NOOOOO.. He admitted the data is flawed!
Good luck with your investment.
I'm guessing you have tons of free shares and warrants for your paid promotion, so you won't take the loss that normal retail investors will..
JMHO
Sad.
<<< btw - numbnuts - patient selection occurred ---long--- before PFS to OS
change in focus ..... >>>
What about post hoc external controls with the sickest of the sick patients as a comp?
Age quod agis
You are absolutely correct..
Abeta is one of pumpers who accuses every person with an alternate view to his/hers to be a basher, a short or Adam Feuerstein himself..LOL Not credible at all and a childish dolt IMO
No serious company changes the endpoints, protocol, then leaves NASDAQ for the pink sheets and ignores the FDA when they have a successful product.
Thanks for chiming in with serious, well though out comments.
Barring any scientific facts, the amount of morons who own this stock is enough to tell you everything you need to know about its chances.
Apparently you can't read, so on ignore you go
<<< try grapefruit juice >>>
Probably more effective than DCVAX in treating cancer with a 500 mg dose of aspirin...
Maybe they will be issuing grapefruit juice along with tote bags at their big booth at ASCO? Can they get a refund for their booth if MHRA issues a rejection this month?
NWBO CHANGED their endpoint and got halted by the FDA,... not me sir.
Yes, and the Placebo outperformed DCVAX.
"Fortunately, the numerical PFS data are now presented: the median PFS was 6.2 (95% confidence interval CI 5.7–7.4) months for patients receiving DCVax-L and 7.6 (95% CI 5.6–10.9) months for the placebo group"
NWBO's original endpoint was PFS, it failed, FDA halted the trial, and then ..... pink sheets... Fact
Maybe go back to school and put off investing for a while?
Publication
Conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.
Please provide evidence of the "publication of a UK Public Assessment Report"
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
Being that they haven't even gotten to an RFI phase yet, your assumptions are ridiculous, at best.. However, if they get an approval, which would be most likely in the Fall, ( if ever) I will congratulate you, I will never apologize for standing by my due diligence standards...
Almost every institution is OUT of this stock, MRQ, they are diluting the shares daily, all respectable exchanges will not host NWBO, and the trial failed..If you are smarter than all the best investors on the planet, I will gladly congratulate you, maybe even buy you a bottle of your favorite spirit. I am neither long nor short, just seeking facts and the truth. I am a fan of successful therapies and people making profits GL
As for your AF comment.... not even gonna entertain that ridiculousness.
And there is this
https://soc-neuro-onc.libsyn.com/website/immunotherapy-for-glioblastoma-lessons-learned
$1.9 Million for all of 2023 in total revenues! LOL
Read the 10k, if you cant read, ask someone to read it to you.
"Importantly, overly positive interpretation of the study data is misleading to patients and must be avoided, as the current data simply do not warrant application of DCVax-L in patients with newly diagnosed or recurrent glioblastoma. Our mission is not to give more treatments to patients but to deliver treatments that improve outcome, based on solid evidence and not speculation."
Would be a miracle if NWBO gets to any approval, anywhere... IMO
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10076936/
NWBO has an aging staff of 20 and none in the UK... So your point is???
We will soon see if NW gets through the assessment phase and moves to RFI... None of us have any control over what happens .... we shall soon see.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10076936/
Whoa!!! "Fortunately, the numerical PFS data are now presented: the median PFS was 6.2 (95% confidence interval CI 5.7–7.4) months for patients receiving DCVax-L and 7.6 (95% CI 5.6–10.9) months for the placebo group.Thus, the clinical trial did not reach its prospectively defined primary endpoint and with that, the investigators de facto declare the randomized trial in its original and prospective
design to be negative."
---- PLACEBO was BETTER than DCVAX! - Do you think MHRA and NICE will ignore this when it costs 150,000 - 250,000 pounds?
The study (NCT00045968) was initially designed in 2007 as a prospective multicentric placebo-controlled randomized phase III trial. Patients with newly diagnosed glioblastoma were to be randomized in a 2:1 ratio to standard radiochemotherapy with either placebo or DCVax-L. With cross-over to the active treatment for the patients in the control arm at the time of progression being part of the study protocol, the primary endpoint had to be progression-free survival (PFS). The trial was conducted at 94 sites in 4 countries (US, Canada, UK, and Germany) and enrolled a total of 331 patients (232 patients randomized to the DCVax-L group, and 99 patients randomized to the placebo group) over a period of eight years (August 2007 until November 2015), with the vast majority of patients (n = 303, 91.5%) accrued between 2012 and 2015. An initial report on the trial in 2018 reported only on the combined overall survival (OS) data of both study arms and failed to report on PFS, the primary study endpoint.3 The argument for not publishing the primary endpoint was an ambiguous statement about an expert panel being required because of the complex determination of progression. Nonetheless, the authors concluded that the patients in this trial were living longer than expected. Now, more than four years later, a second report is available, which is surprisingly named “A Phase 3 Prospective Externally Controlled Cohort Trial”. This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons. The authors state that the PFS endpoint became infeasible because of pseudo-progression issues, however, to the best of our knowledge in no other study that issue has resulted in abandoning the primary endpoint. Fortunately, the numerical PFS data are now presented: the median PFS was 6.2 (95% confidence interval CI 5.7–7.4) months for patients receiving DCVax-L and 7.6 (95% CI 5.6–10.9) months for the placebo group and not statistically significantly different (P = .47). Thus, the clinical trial did not reach its prospectively defined primary endpoint and with that, the investigators de facto declare the randomized trial in its original and prospective
design to be negative.
Not sure what you are talking about- No one should believe either you or me but here is what MHRA says. Care to comment on why the remaining institutions SOLD 82% of their holdings in the MRQ, down about 2.5 million shares to about 400,000 shares?
Assessment
New active substances and biosimilar products
The assessment process includes consultation with the CHM on fixed dates each month. The submission slots will be linked to the dates of CHM meetings. The MHRA may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process.
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.
For new active substances and biosimilar products the orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.
First part of your post: That is all part of the phase 1 80 business day assessment..
The Aug 2023 opinion is irrelevant at this point.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296384/
New active substances and biosimilar products
The assessment process includes consultation with the CHM on fixed dates each month. The submission slots will be linked to the dates of CHM meetings. The MHRA may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process.
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.
See my latest post... MHRA guidelines.
They are just about at the 80 day point... And yes, that is working days. I guess we will soon know if it gets past review and enters the RFI stage.
Too bad none of that is accurate
There's an 80 business day assessment review, then a clock off period, then the remainder of time to to actually consider approval.
If they get past the assessment phase, it would be another 4-6 months , minimum..
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.
Yea,,,.... nope!
I can't confirm the app has even been accepted yet
Age Quod Agis...
Or to quote the great Forest Gump:
~ "Stupid is as stupid does"
FDA passed on the failed DCVAX trial, long ago....
You have failed on the most important investment rule. IMO
bet the jockey, not the horse
(finance) One should invest based on the management team behind a venture, rather than on the product or service being sold.
All the spoofing you need to know about in ONE Captain post..
04/11/24 - 1,201,099,732
04/10/24 - 1,200,500,107
04/06/24 - 1,199,672,730
04/05/24 - 1,198,812,505
04/03/24 - 1,197,237,455
03/28/24 - 1,195,269,485
03/27/24 - 1,194,274,786
03/26/24 - 1,193,493,852
03/19/24 - 1,193,316,128
03/15/24 - 1,193,166,128
03/14/24 - 1,192,908,369
03/10/24 - 1,192,237,685
03/07/24 - 1,190,170,308
02/29/24 - 1,189,970,308
02/27/24 - 1,188,836,983
02/22/24 - 1,188,731,708
02/17/24 - 1,187,812,280
02/14/24 - 1,186,753,180
02/13/24 - 1,186,425,305
01/30/24 - 1,185,680,827
01/27/24 - 1,185,128,327
01/25/24 - 1,182,971,840
01/24/24 - 1,182,454,590
01/23/24 - 1,182,433,108
01/19/24 - 1,181,833,108
01/09/24 - 1,181,176,418
01/04/24 - 1,175,459,031
01/03/24 - 1,173,563,502
Maybe... That is a big "if"
Either way, the company is being diluted into oblivion and those shares will either stay with management or be sold into more dilution...
The big event is whether or not MHRA is going to accept the application for potential approval, or not! If not, nothing else matters... That would lead to a reverse split, tons more of dilution and another 3-5 years of a stock dropping another 90% , All my opinion of course. If the app gets accepted, there will be another 4-6 months of waiting for a possible approval, ( after the RFI and much more due diligence by MHRA)
There are still over 400 million "potentially dilutive securities" outstanding.. As per the 10K
Not quite there yet, buy we don't know how many are held by investors, insiders and/or preferred C shares used for paying interest on notes, salaries and monthly bills...
It's all a big mystery with this management.
However, any NEW shares needed to be issued would require an increase in authorized shares.. ( with current outst. and potentially dilutive, they are just about at the 1.7 Billion level) Nobody is coming in with any industry investments and institutions SOLD 82% of their holdings in the MRQ... Institutions only own a total of about 400,000 shares now... Down 2.5 million shares or so from last qtr.
How so?
Manipulated? Take a look at Captain's share count posts... The only selling pressure is NWBO
Test of $0.47 will be significant
Where's Sojourner? lol
Is NWBO mentioned at all?
Maybe even for the tote bags?
The peanut gallery is quiet all of a sudden
Here's my update, based on the MHRA WEBSITE and not idiots spewing nonsense;
Within a few days we will hear if MHRA is either accepting the application, or NOT.
80 business days from submission is MHRA guideline for initial review/assessment. Then an RFI, ( if accepted) and then 60 business days for NW to respond, and then another 70 business days to make a decision...
This will either be outright denied, or an official approval would take place somewhere in Sep or Oct...in the best case.
Stop the mental masturbation please.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
If you had half a brain you'd be dangerous..
If I ever need a brain transplant I hope I get yours, it has apparently never been used.
Maybe read the 10K instead of asking clowns who know nothing..
There are still over 400 million "potentially dilutive" shares that can be exercised. Nobody knows how many of those will convert and sell but if they want to issue any NEW shares, they will most likely have to ask for an increase in authorized shares.
Ignore these cretins. They think they know so much, wait until they find out how little they know..