If we take just the recently produced documentation, the least we're doing is doubling what previously was being achieved in GBM and other brain cancers, how is this not worthy of approval. I believe it will get better when we have the Journal and the Top 100 information is clarified, but even without that, decades of data don't show more than 5% survival in GBM, we're over 10%, how is that not impressive.
It just happens that we know that add Keytruda, which wasn't of benefit without DCVax-L, you get greater improvements, but that's just from a Phase 1/2 Trial at UCLA, but I suspect that most Oncologists will use it immediately and I doubt if insurance will balk at Keytruda as drugs like it are commonly used off label.
No doubt, knowing what we know today if this trial was just being initiated it would have been formatted differently, but because it was such a learning vehicle do you dismiss it and throw out the baby with the bathwater. I've seen many decisions by the FDA that cost many years and tens or hundreds of millions in trials that were ultimately approved on drugs that improved the prognosis by 10% to 20% on survival, we have a trial that's more than doubling overall survival, I don't believe that they can justify further delay. 100% of the drugs that I believed would be approved were approved so all the FDA did was add dramatically to the cost and give no telling how many patient who may have benefitted no chance to do so if they couldn't get into a trial. Trial sizes are only in hundreds, the need is for tens of thousands or more, the real shame is that all these people with the diseases see what's happening and their helpless in getting drugs they know could be of benefit to them.
I'm speaking only about products intended for potentially terminal diseases. I'm fine if the FDA insists on perfection in approving a new headache med, or something like that. It's products like DCVax-L, where potentially many people will live longer, and some may actually be cured, that ought not to require perfection to be the burden of proof. The idea that a confirming trial would take many years, cost many millions, and result in many more deaths just makes no sense to me, and didn't make sense in many of the other trials I'm speaking about where the FDA did it and ultimately did approve. If those at the FDA were suffering with the disease that products they delayed could have benefitted, I'd guarantee they wouldn't have delayed them. Likewise, when things like shelf life prevented approvals, if they were the ones suffering, they'd have approved the product with reduced shelf life and let the developer improve it rather than waiting for the improved product to approve the drug that was approvable except for shelf life.
Gary
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