I believe we need to be realistic about our expectations. One poster hoped that all, or nearly all of the last 31 people to be added to the trial are still alive. While I wish it were true, I believe it's an unrealistic expectation at 48 months or more. Frankly 15 still alive would be about triple of what the SOC would offer.
I know there has been talk of production improvements in the DCVax-L product, no one from the company has confirmed this to my knowledge, but if it were the case, and the regulators agreed to it, perhaps the last 31 did better than what was achieved previously. It would still be a miracle if these changes kept all, or nearly all alive. In fact, if they were all alive a year ago I would have thought they'd have all they needed to go to the regulators for an immediate approval.
I do believe that the current FDA philosophy would allow a product improvement without starting from scratch if that improvement were essentially chemically the same, but perhaps the purity was improved. If chemically the formulation changed, they'd want a new trial. The FDA has certainly spoken about being more flexible, trials which previously couldn't be modified once underway seem to be permitted to do so, and I think it's clear that this trial has done that. The new SAP is clearly based on lessons learned while doing the trial. Had the trial never been modified, it would have probably ended years ago, and very probably would have missed established goals. It would have shown that a new trial could have been initiated which would lead to an approval based on very different criteria. The costs and time of doing the additional trial would almost certainly been far greater than adapting the trial as they've done.
Gary
