That’s one of the issues with not having entered into a partnership or some form of collaboration with a Big Pharma company. NWBO needs a larger player to carry their water with the FDA, and provide cover from other Big Pharma donors that exert influence.
I don’t even like discussing this subject for a host of reasons. But it’s an identifiable risk.
Forgive me for butting in Umibe, but I beg to differ.
Perhaps what you say is true under previous administrations. May I ask if you have worked with the regulatory agencies in the U.S. under the current administration? It seems to me that most of them are now headed by former industry lobbyists who seem much more interested in loosening regulations. This may be a good thing in the case of the FDA In particular. I’m sure that you’ve noticed the recent change in direction by the FDA under former Commissioner Gottlieb with their efforts to speed up drug development and the issuance of new guidelines for surrogate endpoints, qualifying biomarkers, real-world evidence, patient reported outcomes, to name a few. Remember this speech by Gottlieb https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-comprehensive-cancer-network-policy-summit-06252018
“What should we do, for example, guided both by ethics and science, when a new drug in a heavily pre-treated group of terminal cancer patients, is in a Phase 1 study where it shows a dramatic response in more than half of these patients? . . . And how we randomize patients to such a treatment?. . .
One is the use of seamless drug development programs, where drug developers can plan to quickly expand enriched Phase 1 cohorts, and evaluate the drug in one continuous clinical trial. This leapfrogs the traditional sequential three phases of clinical trials. It eliminates all of the time spent starting and stopping drug development in between each of those different stages.
We didn’t evolve our approach overnight. And we didn’t evolve on a whim. We followed the science.
And we followed the growing refrain from the broader clinical community, and especially from patients, who themselves compelled us to chart a new course because of the way that this science is bringing with it new opportunities to extend life.
Let me take a moment to reflect on those opportunities that we’re seeing, and take measure of what’s been realized on behalf of patients. Enriched trials can more easily demonstrate a robust impact on intermediate clinical endpoints or surrogate endpoints that are likely to correlate with long-term clinical outcomes. Effects like tumor shrinkage or progression free survival can translate into the ability of patients to stay off more toxic regimens for a longer stretch of time, therefore improving their quality of life. These observed effects may challenge our ability to achieve clinical trial equipoise, which is the doubt about whether new therapy may be more effective than the existing standard of care. This is especially true when there are few or no effective treatment alternatives.
Under these circumstances, where we know a drug can produce a robust response in a tumor that’s otherwise hard to treat, we may not be able to ethically randomize patients. Pivotal trials testing these products are also likely to have crossover designs, meaning that if a patient’s cancer grows on the comparator treatment, then the patient is switched over to the experimental arm. Both arms receive the experimental drug, although in different sequence. Statistically, this may make it difficult to show an overall survival advantage for the experimental arm. Patients aren’t left on the comparator arm for long enough to show that they would have died sooner if left off the new drug. There’s a simple bottom line here. When new drug shows a robust effect on things like tumor size or tumor progression, patients are understandably less willing to forgo a new therapy in the name of a good “p” value."
It almost sounds like he’s talking about Northwest Biotherapeutics doesn’t it?
Simply based on the information arm patients and the blinded data presented to date, it is clear that Northwest will provide some very compelling evidence of efficacy and long-term survival when the final data is analyzed and presented, This evidence will not only include extremely long-term data for those patients admitted into the trial, but it will likely also include information on all the treated patients that were excluded from the trial like the 32 with rapid progression, the 55 in the information arm, the approximately 100 EAP patients, and possibly patients like Brad Silver, Kat, Kristyn Power Sara Rigby, Alice and others. All this evidence may or may not be included in the BLA submission, but based upon the new guidelines and more flexibility of the FDA and other RA’s, I think it’s likely they will want to evaluate the totality of evidence in making their decision. I find it extremely difficult to believe that based upon this large body of evidence of extended survival (the gold standard) and the extremely benign safety profile of DCVax, for one of the most deadly of cancers, with no other viable treatment options, that regulators won’t find a way to approve it.
But if they did? Oh, there would most definitely be a HUGE outcry from the patient advocacy groups. They, along with many neuro-oncologists and their patients have been waiting a VERY long time for this.
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