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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.
Worked in BP BizDev so have a pretty good visibility of the decision criteria. NWBO ain't cutting it.
BPs don't start deals unless they are committed. NWBo could be bought for pocket change. They have no cash to do more trials, barely have cash to pay the rent and have had no interest from BP. Merck has been paying big bucks for their deals and clearly aren't interested in NWBO -- they seen the dubious clinical trial. They have no reason to buy. Personalized oncology treatments have not done well -- just look at CAR-T's.
But yet NO BP has shown any interest in a NWBO deal. What's that tell you??
Certainly ain't crying and name isn't Chris. Strike two.
In your dreams. If it was, NWBO would have been snapped up already -- instead, stock is hanging around it's 52 week lows. Merck has bought multiple other oncology biotechs and could buy NWBO with pocket change from their waiting room couch. Instead -- crickets.
Not a single BP has done a deal with ANY OTC biotech penny stock in the last decade. NWBO's dubious trial results aren't going to change that.
Nice fantasy. Merck has done multiple biotech acquisitions, is very knowledgeable on NWBO's dubious trials and has shown no interest in a deal with NWBO. That also goes for many other BP. There hasn't been a single BP deal with a OTC biotech penny stock company.
Dr. Kory is NOT a reliable source. Been hyping ivermectin for years even after repeated trials proved it was ineffective. He was making money selling it online.
Dr. Kory has also had multiple journal articles pulled from journals for dubious data.
BPs who are interested in a biotech have no problem ponying up the big bucks required. No BP would put up money for an insolvent OTC penny stock with dubious clinical trial data. They have clear understanding that NWBO tossed out their failed primary endpoint and redid the trial after it was virtually completed.
No BP BizDev person would would bet their career on something all their clinical people would laugh at.
Means nothing related to Merck having any interest in acquiring NWBO. Merck participates in many combo trials with Keytruda and most they don't buy the partner -- the trials just give oncologists evidence of treatment protocols using Keytruda. Keytruda is going off patent in three years and Merck is looking for new horses to ride in their future. They've had over 2 years to look at NWBO and have bought half dozen other biotechs -- NONE are NWBO. Ain't going to happen.
But yet Merck keeps buying oncology biotechs and clearly has no interest in NWBO. They've has several years of looking at any NWBO clinical data -- and they clearly aren't buying it.
Sponsor can release the data from a clinical trial WITHOUT peer review. In fact, NWBO did in a press release and in public presentations (NYAC and a external event at ASCO). Neither were peer reviewed. And then the medical press picks it up and publishes it and distributes it to medical professionals. So it gets out to the medical community WITHOUT PEER REVIEW.
Yes, reps can only distribute reprints of peer review articles, but non-peer reviewed trial data is distributed in other ways, just as NWBO did.
SPORE NIH/UCLA Trial is NOT A NWBO TRIAL. They have no rights to the trial data. It is not listed in ANY NWBO SEC filings that include all their clinical trial activity. UCLA will release data or Merck or Poly-ICLC who sponsored the trial have access to it. NWBO has no RIGHTS TO THE TRIAL.
Once again Merck, who has seen ALL DCVax-L clinical data is buying SOMEBODY ELSE.
"Merck has struck a deal to buy Harpoon Therapeutics for $680 million, beefing up its oncology pipeline with a portfolio of T cell engagers."
If NWBO's data was sooo good, there would be BP lining up to buy the company. But just hearing crickets.
Sorry, no regrets. Studied these clinical trials and they raise serious questions as to whether you can make any conclusions.
Immunotherapy has been around for decades -- CAR-T for example.
NWBO has not made any claim of participation in the NIH/UCLA SPORE trial in the clinicaltrials.gov post, the SEC filing, company press releases. You can be damn sure NWBO would be hyping it if they were but only crickets.
But yet, NWBO is making NO claim to the UCLA/NIH SPORE Trial -- not in any SEC filings that reported all trials done for DCVax-L, or any press release, or even in the NWBO website that lists all clinical trials, and again has NO mention on the UCLA/NIH SPORE trial.
Well tell me, if NIH/UCLA SPORE Trial is using DCVax-L, why wouldn't NWBO feature it on all of it's communications?? NWBO does not include it in their "Clinical Trials" section of their website, list it with all the other trials on their 10K and 10Q SEC filings. NWBO sure is NOT claiming it in any of their documentation of clinical trials, even though they have all NWBO DCVax-L trials listed including DCVax-L Direct.
Delusional.
No it's not as the UCLA SPORE Trials aren't using DCVax-L produced by NWBO's manufacturer. Not sponsored by NWBO, not produced by NWBO. Therefore they can't claim any of the results.
But yet the combo is not a NWBO vaccine, not produced using NWBO manufacturing and not usable by NWBO for any approvals.
The crossover was a rescue medication for patients that progress. It is a required humanitarian requirement and what patient would take a risk without knowing they would have some kind of rescure if the test drug failed in a trial. In 2018, Dr Liau published the interim naive GBM results for the original trial protocol -- No R/R GBM was part of the trial protocol. Only after they knew the PFS primary endpoint was going to fail, did they decide to redo the protocol and add a R/R GBM metric that required an ECA as there was no control available. Then they turned the "rescue" treatment into the crossover to add the R/R GBM arm (not prt of the original protocol). It was created and released 2 WEEKS before the data lock. The only document relevant was FDA's Comparator Guidance document which clearly states the ECA must be created and approved PRIOR TO THE START OF THE TRIAL not right before the trial was complete.
FDA has very clear ECA guidelines. NWBO viloated most of the guidelines. They certainly aren't BS as they are the criteria that FDA uses to determine acceptance or rejection. Dr. Liau and Ashcan totally redid the trial protocol 2 weeks before datalock. Guidleines in ECA is they are designed and executed BEFORE the trial BEGINS.
FDA Guidance document is the essential source of ECA guidelines. NWBO failed to meet most of the guidelines.
Well NWBO chose and had agreement with the FDA that PFS was the primary endpoint. PFS is an acceptable endpoint according to FDA's Cancer Trial Guidance and even Dr.Liau is using PFS in the NIH/UCLA SPORE Combo trial as the leading efficacy endpoint. Changing primary endpoints at the very end of the trial is very suspect -- especially when you failed the original primary endpoint -- Very Shady. Doubt the FDA will buy it.
Not my view -- the FDA's view from their Guidance document. Yes, it is required to recruit patients and for progression treatment. But the Crossover design was as a rescue treatment in the original trial design (trial was designed for naive GBM only). All patients had an additional treatment once they progressed.
But after NWBO saw they were going to fail the PFS primary endpoints (interim analysis would tell them), they decided to totally redo the protocol and make it a different trial adding R/R GBM arm after the trial was virtually completed and drop the placebo and create an ECA comparator when the trial was virtually complete.
All biotechs would love to have the chance to redesign a failed trial and NWBO did just that. But Regulators have seen it all and this is not going to fly.
After the Trial is virtually done?? Tossing out the failed primary endpoint and redoing the WHOLE protocol 2 weeks before datalock??
Nothing sounds suspicious like that set of events. Just read the FDA Guidance -- ECA violations (should be done BEFORE THE TRIAL STARTS).
Doun't see the FDA buying it.
Not my view of ECA, FDA's VIEW. They publish their guidelines and it is clear NWBO is clearly not in compliance.
I said the crossover was the rescue medication for recurrent disease whether treatment or placebo. The trial was designed ONLY for naive GBM patients.
It was only after they knew they had failed the primary endpoint they scrambled to redesign the trial and added the "recurrent GBM arm" from the placebo arm patients treated with the rescue. Clever, but not the original trial design. All this was designed AFTER the FDA partial trial had stopped the trial, and two weeks before the datalock.
No placebo and had to create an ECA after the trial was virtually over. FDA ECA Guidance required ECA design and analysis BEFORE the trial starts.
So much bias from "after the fact" ECA. ECA design failed to use patient level data, consultants created data from the graphs of the trial data. Unbelieveable. Then there was the dubious screeners -- NWBO required full resections, multiplte ECA trials allowed biospsies which has a much higher death rate to begin with. Now wonder 7 publications outlining the trial deficiencies and bias and the inability to produce a legitimate conclusion. And the FDA will clearly have considerable problem with the major changes and all the violations of FDA Guidance.
You missed the design of the trial -- it was a NAIVE GBM trial and the crossover was the rescue medication for the placebo arm. Only when the trial was virtually completed and the PFS primary endpoint had FAILED, did they attempt to post hoc dredesgin the trial to add an R/R/ GBM arm using the placebo arm.
It was designed this way, it was post hoc redesigned this way. ECA arms are required to be done BEFORE the trial begins to avoid the inherent bias built into ECA designs (per FDA Guidlance document). NWBO's outside consultants scrambled to assemble ECA dataset without having access to the patient evel data. They actually just created the data of the the graphs in the trial publications. The screeners had variantions -- some permitted biopsy only surgery vs. NWBO's trial requiring complete resection. There are 7 publications that detail the deficiencies in the trial and the bias that makes any conclusions from the trial suspect.
NWBO had done the Interim analysis that gave them a clear view that the primary endpoint was not likely to show a positive outcome. WHen all patients had similar results, it is pretty obvious. So they make the decision to flip the trial into the totally new protocol. It was desperation to try to survive, but they did it. The ECA post hoc already has a significant test product bias (per FDA Gudiance), and now they have to deal with regulators that have plenty of experience watching biotechs trying to spin trials to create positive outcomes. Don't FDA is going to buy it.
Since you missed the ECA guidelines here is the key guideline that NWBO mised:
"Any matching on selection criteria or adjustments made to account for population differences should be specified prior to selection of the control and performance of the study."
NWBO clearly DID NOT make any "selection if the control" prior to the start of the trial. In fact it was done when the trial was virtually completed, 16 YEARS after the start of the trial.
FDA Guidance: "It is well documented that externally controlled trials tend to overestimate efficacy of test therapies."
So guess you didn't read the FDA Guidance on Comparators. It's pretty clear and NWBO certainly violated the guidance.
Doc, somehow Dr. Liau finds PFS perfectly find for her NIH/UCLA SPORE Combo trial as the leading efficacy metric. Only seems that PFS is not acceptable when NWBO fails to meet their primary endpoint.
JAMA Oncology doesn't VALIDATED anything -- they just accept a publication.
Try reading the 7 publications that challenge the legitmacy of the NWBO trial and conclusions. The trial bias is such that no legitimate conslucsions can be drawn. The ECA process completely violated the FDA Guidance which requires the selection be completed BEFORE the trial starts. But not NWBO, they wait until the trial is virtually complete and they know they are going to fail their primary endpoint.
The trial was designed as a NAIVE GBM trial, They offered a rescue treatment for paitients had recurrence whether placebo or treatment arm.
After the trial failure, NWBO decided to "rescue" the trial by going to a ECA comparator and dropped the placebo controlled -- this was two weeks before the Datalock. they them created a RECURRENT arm for all the patients that had recurrence. Totally post hoc revisions. FDA Guidance requires ECA comparators to be designed and computed BEFORE a trial begins. Doubt the FDA will buy it.
Never have I heard a P3 trial take SIXTEEN YEARS!!! Whole development programs don't take that long.
Never shorted, don't plan on it. Have spent 20+ years in in biopharma world. lauch team on the most successful drug in history. and strategy consulting for much of the Top 20 pharmas.
Personalized cancer treatments has all struggled because of the substantial cost. CAR-T is struggling even with BP commercial muscle. Dendreon outright failed.
BP doesn't spend a billion without a much more rigorous process that NWBO has run. And they certainly wouldn't take frigging 16 years to do a trial, or 19 months for a topline, or more than a year for an application. They would save a lot of money just on doing normal turnaround times that NWBO has shown its poor management by the years of additional unnecessary cash burn. And then BP certainly wouldn't toss out their primary endpoint when it fails and redo the trial after the trial is virtually complete. People would be fired. But NWBO is desperate and has no other choice or they are toast (even though they are still likely toast).
20+ years in biopharma world, launch team for the most successful drug, strategic consultant with many of the top 10 pharmas.
Show us Where NWBO claims they are part of the NIH/UCLA SPORE Keytruda combo trial?? Read any of the SEC filings and NONE have any reference to the trial as using DCVax-L. You can be damn sure that NWBO would be touting it if they could. But no.