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The MAA was not for NWBO it was for their contract manufacturer. Compassionate Use programs are for UNapproved drugs and many developmental oncology drugs have this approval.
FDA approved a DCVax-L trial NOT DCVax-L for commercial use. BIIIIIG Difference.
You have no idea what FDA has told NWBO. As NWBO spent millions developing an approval request package -- Why didn't they apply to the FDA?? If FDA was encouraging, they certainly would have, but they didn't. Getting approval in UK has no bearing on FDA decisions.
Well NWBO didn't have the confidence in their data to file it with the FDA. And let's see if MHRA believes it -- sure taking their time reviewing it. And even if MHRA approves it, it is the worst market for new, expensive oncology therapies. CAR-T, a well-established, proven treatment, took 5 years to get any UK funding after approval, and it is rationed for only 100 patients by the NICE charity. NWBO isn't going to survive on that type of outcome. So that's the best outcome NWBO is facing.
Because your written word is not relevant to reality.
Sorry, read the FDA guidance on oncology trial design and external comparators. External comparators are required to be approved prior to the start of the trial.
FDA doesn't care how many clinicians are on either site. They review the clinical trial protocol (did they approve it), the clinical data (efficacy and safety). It's not a bunch of clinicians voting that has any bearing. Notice NWBO didn't have the confidence to even file with the FDA -- they know FDA would blow them out.
Remember, DCVax-L FAILED the original agreed to primary endpoint and suddenly two weeks before the end of the trial (after they knew they failed from the interim analysis) they totally redid the trial -- new protocol, new endpoints, even the trial design, even added a new arm to the trial -- NONE of it was approved by FDA.
Get your story straight -- here's what I posted: "They have the original protocol and clearly can see how it was manipulated in the last two weeks of the trial." were NWBO paid clinicians or NWBO paid consultants/employees.
The external comparator had considerable bias, the nearly post hoc protocol added a totally new trial arm in just the last two weeks (rGBM). External; comparators are required to be FDA approved BEFORE the trial starts, not when the trial is just about completed. No wonder NWBO didn't file with the FDA -- they know they will get it rejected. Getting approved in UK will do little in the way of revenue. And they have little chance of an U.S. approval. Sad.
DCVax-L required every trial patient to have chemotherapy, radiation and be completely resected. That was the protocol and that will be the label if it is approved.
No it doesn't. FDA does the review of the trial design themselves. They will look at the literature, but it has limited influence as it is not hard to get clinicians to sign onto clinical trial publications -- they need to do publications for their job security.
Let's see how MHRA views this -- they sure are taking a long time to wade through all of NWBO's B.S. They have the original protocol and clearly can see how it was manipulated in the last two weeks of the trial.
The ratio of paid clinicians versus the independent clinicians challenging the trial design and protocol has no bearing on a drugs approval and success. You can buy co-authors.
Sad to not understand independent clinicians work for many competitors, just like most of the 70 NWBO clinicians have done.
Journal articles that question other articles are not peer reviewed like clinical data articles. Comments by credible GBM clinical researchers are credible and read by regulators. Many GBM clinicians work for many of the competitors and does not indicate bias as you claim.
Sorry, the external comparator was not public until the final two weeks of the trial. Peer review is not the same as regulatory approval. FDA has clear guidelines that indicate external comparators MUST be approved PRIOR to the trial beginning, not after the trial is virtually completed.
Novocure trials DID show significantly improved survival benefit -- read the trials.
70 Doctors "behind" the publication were all getting fees from NWBO and were operating trial sites. The publication with the totally new protocol was written by internal NWBO management and their consultants and the 70 clinicians signed on -- they were not independent.
Notice that NWBO didn't file for FDA approval -- because they knew the FDA would reject it. UK approval is never going to provide NWBO with enough revenue to survive. None of the CAR-T immunotherapies have made any material cash after over 5 years of approval.
7 journal articles point out the clear bias of redoing the protocol TWO WEEKS before the end of the trial. In addition, FDA Guideline for an external comparator requires the comparators be selected and approved BEFORE the trial begins. NWBO did it two weeks before the trial was CONCLUDED.
Sorry, I'll believe the seven journal articles that all conclude the bias built into all the protocol changes including external comparator. Notice NWBO didn't even file an application with the FDA. They know the FDA would reject the complete protocol change two weeks before the end of the trial.
Biased trial that won't be accepted by the U.S. FDA.
IQVIA, the largest clinical trial operator, summarized the FDA's guidelines:
"The FDA expects sponsors to have a finalized protocol before initiating an external control trial. The FDA is looking to dissuade sponsors from adding the external controls after the completion of a single-arm trial, and instead, proposes upfront planning to allow inclusion of the external control arm design and analytic approach along with the trial protocol. It also asks that sponsors pre-specify their plan, how they want to measure the different aspects of the design and the data, and how they would analyze any confounders and reduce sources of bias. Design elements for consideration include the study population (Is it exchangeable with the experimental arm? Does it have the same eligibility criteria?); treatment (Are the treatments comparable?); immortal time bias (Are the timings from exposure to outcomes the same?); and, outcome assessment."
Clearly NWBO DID NOT DO THAT. They completely changed the protocol and added an external comparator TWO WEEKS BEFORE THE COMPLETION OF THEIR CLINICAL TRIAL. Clearly violating FDA guidelines. That's why NWBO didn't file for FDA approval.
Statement of fact -- he is paid by NWBO and is promoting the drug with the totally redone protocol and not referencing that fact. There have been 8 publications that have documented to trial defects. NWBO has violated FDA guidelines for oncology comparators.
Sorry, he's become a paid shill.
Ashkan that's on the NWBO payroll?? He's a shill.
And clearly NWBO's application was NOT deemed as "high quality." Based on the clinical data, that would be very true.
Except for the 8 peer reviewed articles that challenge the legitimacy of the clinical trial revisions done 2 weeks before the completion of the trial.
Totally new comparator (one required to be approve BEFORE the trial started), change the protocol, endpoints, and experimental design. All were well detailing in these publications.
Speaking of B.S. -- manufacturing site approval is NOT a drug approval.
FDA doesn't care about other regulator decisions. It's not a "shaming" exercise. The question is why didn't NWBO file with the FDA?? After all their major protocol manipulations, NWBO knows the FDA would reject it.
Also, the UK market is very small for very high cost oncology treatments. Gilead's CAR-T treatment too multiple years to get any NICE coverage and it is patust their charity that limits coverage to only ~100 patients. No oncology drug company can survive on just revenue from the UK market. NWBO already is providing the drug to any patient through compassionate care but is getting very little cash from it.
Really?? A biotech is dependent on clinical trial results -- they are ALL material as they are the determinant of a biotechs success and economic future.
Sorry, IF NWBO has a drug in a clinical trial it IS MATERIAL AND IS REQUIRED TO BE DOCUMENTED IN THE SEC FILINGS.
But yet for quarter after quarter, NWBO has made NO mention of the UCLA trial. If they have DCVax-L in a trial and are NOT reporting it, they are violating SEC legal requirements.
Nice Self-Portrait!!
I've had over a dozen biotech's sold to BP or ramp for P3 and approvals. Have worked in the biopharma industry of over 20 years and on the launch team for the most successful drug launch of the day. Also a new product strategy development consultant with over 12 of the leading BPs.
You can pat yourself on the back for a low price, but you are still facing a risk of failure to be approved which pretty much puts you back in the same hole you originally bought it at. Certainly not a SWAN investment. UK approval is not going to make it for this drug. For some reason NWBO is afraid to file with the FDA. Oncology drugs require approval in the U.S. to make the economics work. Good luck!!
Always a sign of an investor trying to blame others for their poor investment decision. How much have you lost?? You didn't cash out when you could have -- so you have lost -- opportunity cost. You've clearly tied up cash in a poor investment for a loooong time.
Always a sign of an investor trying to blame others for their poor investment decision. How much have you lost??
Always a sign of an investor trying to blame others for their poor investment decision. How much have you lost??
Sorry, never shorted, never will. There is NO pre-approval. Poor investors blame shorts for their troubles. How much ya lost??
Comical - one man's rationality is another's irrationality. You seem to have resorted to name calling and other childish arguments. You still haven't provided a legitimate argument other than the manipulated clinical trial that has had many clinicians provide detailed fact based arguments. But time will tell.
I'll get my investment advice from somebody who knows what they are doing. Clearly, that's not you.
It's an issue for MAA. Same criteria in UK as FDA.
Note the trial used the "artisan" technology and not Flaskworks. So the regulators do not have the validation that Flaskworks produced DCVax-L that is comparable efficacy. FDA requires comparability testing to prove that one production method provides the same efficacy. NWBO hasn't done that so MHRA may require it be done before any decision.
Patients can currently get DCVax-L through the U.S. right to try program but evidently very few have seem to be interested as NWBO is reporting very little revenue that would only come from that program as the drug is not approved for commercial sale. Seems most oncologist's are not buying the clinical data.
But yet NWBO makes NO CLAIM for the SPORE/UCLA CLINICAL TRIAL!! Not a single mention in ANY SEC filings that document all the clinical trial activities.
NVCR doesn't screen for unmethylated or methylated patients. Look at the screening criteria on their recent German trial:
https://clinicaltrials.gov/study/NCT03258021?term=NCT03258021&rank=1#participation-criteria
You mean that just a pittance from a VULTURE FUND isn't enough to commercialize a drug??
Management just borrowed another $11 million from the only creditor that give them cash -- Their vulture fund that feeds of failing biotechs. No revenue but they are obligated to pay it back in a few years. Claim they are spending the money on the Sawston lab. Wonder what they put up for collateral??
20 years in BP world you do a lot of things.
NICE won't fund DCVax-L, it will be part of their charity with significant rationing. CAR-T took almost five years after MHRA approval to sell over 100 patient doses a year at greatly reduced prices. No oncology drug makes any material profit in the UK due to price restrictions and rationing coverage.