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Or that Advent is working on the replying to an RFI.
I agree the IA likely did not disclose the actual PFS results at the time. But they would have provided an opinion on halting the trial early and for what reason. Whatever they might have said would be an issue. Even if they said to continue as normal that tells NWBO that there was not sufficiently good results to halt for efficacy,.
Of course we all know what the result if the IA actually was. The DSMB saw that PFS was failed. Does not matter it failed, it did. And knowing that NWBO changed the endpoint.
And before you say we don;t know the DSMB called the primary futile, BS. We all know the actual PFS results and treatment did well worse. The DSMB would have seen that, They called it futile. The FDA halted screening of new patients,.
Did you forget to read the JAMA paper?
You should have actually read your second link. It describes exactly what happened to here.
If, however, the decision to change the endpoint is not independent of the trial data, then ‘‘ cherry-picking’’ is a serious concern. New endpoints may be selected because they displayed a trend towards signi?cance, while other candidate endpoints may have been examined but not selected or reported because they failed to display a desirable trend; this increases the chance of false positive (type 1) errors. In the Physicians’ Health Study [10,11], the trial’s data monitoring committee (DMC) recommended termination of the study because interim data seemed unlikely to show any bene?t of aspirin with respect to the primary endpoint, total mortality. At the time this decision was made, there was evidence of bene?t with respect to myocardial infarction. However, the United States Food and Drug Administration did not approve an indication for aspirin for the prevention of myocardial infarction, because t his was not the prespeci?ed primary endpoint.
You do know that that the SAP stated that the efficacy IA was performed in 2015?
Yup, that risk factor from the 10K cannot be found in the 10Q. And neither can any of the other dozens of risk factors.
The 10Q did not relist any of the risk factors from the 10K. It referenced them all instead.
Item 1A. Risk Factors
Applicable risk factors are set forth in the Company’s report on Form 10-K for the fiscal year ended December 31, 2023.
At a minimum we know as a hard fact that an efficacy IA was performed prior to the endpoitnt change.
The FDA says that changing the endponts based on information from the trial is a big no-no. And the results of an IA is huge wrt the likelyhood f the initial endpoints failing.
Well, DCVax did get a mention in the last Q of the session by some poster asking what the doctor thought.
Basically he said the trial was a mess because of the changed endpoint. He acknowledged there is a possibility the treatment can work, but not yet proven.
Time for the usual crowd to post how he is just another hater
Parties did not consent to magistrate Judge. Case will stay with Judge Woods.
Not sure, but I think Judge Woods can still shop some work off to Judge Stein, just not the entire case.
They could have the Revimmune deal all set to go. Getting the "legal operating company" notice was huge.
Think LP can negotiate a good deal?
So we still have no RA noting an approval (and they would list it).
We have the CRI website asserting it is approved.
We have the Oncovir website asserting it is not approved.
I will take the the owner of the drugs and the RAs as the better source, CRI would not be the first catalog of drugs get one wrong.
NWBO stated that they would disclose any major hurdles or obstacles and they have not. Les literally said no news is good news
I understand quite well the fixed plus incremental costs and how that negatively effects low run rate operations.. Though I am skeptical of the current numbers being fair, I will let that slide and go to the core issues.
First and foremost is that the revenue number does not match what anybody expects. Lower by a lot. The explanation by many that the reported revenue is not real is nonsense. Advent cannot reasonably be deducting costs from receipts when they are already being paid to manufacture.
Also, why 2 facilities are being paid for? They are not even close to capacity of even the London facility alone.
And let's not forget the fact that Advent basically gets a nice shiny facility for chump change. $145k/y in rent.for as long as NWBO has the lease on Sawston. That covers 14k sqft of clean rooms, labs, cryospace and even hallways in the GMP approved facility. Nice deal.
Last year NWBO paid Advent $14.9M to manufacture and run Specials. This does not include the payments for the SOWs. It has increased to that much because they now paying Advent t run ops in both London and Sawston.
One would normally expect that given NWBO pays Advent to do this, NWBO gets the revenue, Yet, the revenue was about $1.8M. Since Advent is already being paid nicely by NWBO for Specials, it makes no sense that Advent should also keep the revenue.
Related party transaction do not require conspiracies.
We know big pharma pays the bills for our fda and majority of docs on the panel will be bought and paid for !!!
Will have to wait a while for that news flow
The most recent CHM meeting with published minutes was May 2023
The most recent OEHAG meeting with minutes was Sep 2023 meeting.
Yes, only a few drugs are mentioned because MHRA has very few new drugs that are not basically rubber stamps of EMA approvals. 8 last year.
The German treatment is NOT the same as DCVax-L as the German version is missing the patient’s tumor lysate… which is kinda key.
Two components are required for manufacturing an individual cancer vaccine:
. Patient's immune cells.
. Components of the patient's tumor.
The first one is obtained during the leukapheresis procedure, when about 200 ml of blood is collected from the patient's vein. German specialists immediately separate the blood into components and return plasma, erythrocytes, platelets, and unnecessary leukocyte fractions to the patient. To manufacture a vaccine, only one type of immune cell is used, i.e. monocytes. Leukapheresis takes a little time and has no side effects.
The harvested monocytes are cultivated in a GMP-certified laboratory, where healthcare professionals stimulate their transformation into dendritic cells. Young dendritic cells actively multiply on a nutrient medium. After receiving the required amount of cellular material, they are "acquainted" with the components of glioblastoma. This can be a tumor lysate (if a biopsy or surgery was performed) or synthetic glioblastoma peptides (if there were no interventions). As a result, dendritic cells are trained to resist the tumor masking and stimulate the destruction of its cells.
BB said there won't be a CHM meeting. They are not required.
There is absolutely zero clinical data on dvax that is of negative value or impact to the approval process.
Kam8 - The broad leeway granted to this patent is breathtaking. Effects on immune modulation is clearly unaccompanied by what those specific modulators would be. Unless I missed something? This patent is worth billions imo.
Poly-ICLC is already an approved drug
We promote Hiltonol® as an experimental viral mimic and broad activator of innate and adaptive immunity. We have partnered extensively with both commercial companies and academic institutions.
Oncovir manufactues GMP grade clinical material for use in approved regulatory settings and preclinical material suitable for preclinical and scientific exploration
Someone always sell the shares in last minute to make sure it close red every single day. It has happened so many times.
All cause mortality was 5%+ more with subcutaneous administration vs traditional IV. Not really something being hoped for when doing the study. OS not reported nor PFS. Best wishes.
Confirmed. Approval is done and announced by Monday. All shorts MUST cover in the next 2 hours.
Short squeeze of the century starts in 2 hours.
NIMO
Manibio - The "NEW ORDERS" is big blow against the defense. It certainly not a sign of capitulation by the court. That's huge in my book.
Not so fast Reefrad, had several meetings with a person who represents one of the largest insurance companies in the US, and they are very interested in NWBO for many reasons as present SOC is becoming more cost prohibitive, IMPO.
All eligible national Marketing Authorisation applications submitted before 1 January 2024 that were awaiting first assessment
That is great news newman!
So now the MHRA will approve 609 days after FDA/EMA... first approve it.
Do you know when NWBO plans to submit to any of the others?
The defendants agreed in their first MTD that they gained only about $64k spoofing.
But there are 61M shares worth of convertible debt outstanding.
Yes, clients.
For a bid to be a spoof, the party that placed the bid must have intent to manipulate the market. That is the law.
It is fairly likely that many or all of the bids being asserted here, and in Harrington, were from clients. Proving motive w/o access to the parties records would be difficult.
If the NWBO case goes this far, might be interesting to see who might have been be trying to spoof the price down in the windows where NWBO was selling based on that price.
That is reasonable.
Regardless, the MRHA says they would typically provide 4-8 weeks notice of an inspection. Does a shutdown for a deep clean take that long?
Looks like it's dcvax-l, but no mention of it.
A guess, but Yervoy plus Optivo looks obvious..
Dr Scolyer has been involved with that combo in melanoma, and a P1 has been run in rGBM.
As far as press, maybe the press is tried of the 2 decades of hype from NWBO?
I stated very clearly that the MHRA is not the EMA but that many of their regulations derived from the EMA pre Brexit
BTW, have you (and Flipper) not stated that if no RFI happens approval would be in 80 days?
Anybody have a calendar?
No. Accusing them of using carefully chosen words to get the fan club to leap to wrong conclusions.
A clarification to a document does not imply an addition, or change, to it.
When people ave to try and parse management language they should get a clue they are getting played. LP could just have said what happened, instead she drops bread crumbs to allow dot connections.
Why? It makes no regulatory sense. An maa evaluation clock day one does not default to the validation confirmation date. Ex is throwing sh_t against the wall.
Scenario two (validation supplementary information requested)
. The applicant submits an application that is not in accordance with the Agency's guidance (see below: What are the main principles that my application should follow in order to pass validation successfully?).
. The Agency will ask the applicant via a request for Validation Supplementary Information (VSI) to submit the additional information, clarifications or corrections.
. The applicant provides the above additional information within the validation timeline. If the additional information submitted is as requested, the Agency will confirm the positive validation to the applicant.
. The scientific evaluation will start on the next available start date according to the Agency timetables.
Yes, try to understand what he said though.
He says if MHRA had informed NWBO of any bad news then NWBO would have to disclose. As NWBO has disclosed no bad news, there was no bad news from the MHRA.
No, the "no news" was saying that NWBO has released no news. We know as a fact that MHRA has disclosed news to NWBO, so clearly he did not mean no news was provided to NWBO from the MHRA.
Also, there is the timeline. If the clock start was March 4, then the RFI would have been expected just a few days ago, After the interview was recorded.
Less never said they did not receive an RFI. He implied they did not receive any bad material news because they would be forced to disclose it.
An RFI would be considered normal, not any sort of material news in need of disclosure. That posters around here fail to understand the process does not matter,
The expected timeline is March 4 (the submission slot reset after the MHRA certified any clarifications + 150 + 60. That would be Oct., leaves will be turning colors.