It’s a problematical message, because it claims superior efficacy over current treatments. That may well be the case, but patients don’t know this data has not been publicly unblinded with peer review still unavailable. They just see the statement that DCVax is better.
Here’s what I suspect is happening. NWBO needs to run parallel testing for Flaskwork’s automated closed system manufacturing. To increase those numbers, they need compassionate care batches to be processed at Sawston. To increase compassionate care cases, they either need unblinded data released with supportive peer review, OR, they must get good press prior to the actual science data being revealed. Good press pointing towards efficacy is not science, but one might think it’s ok temporarily if the company KNOWS that the unblinded data and peer review (and likely regulators) will back them. That’s a huge gray area. If the company knew the unblinded data and/or data was not supportive, than the article would clearly fall in a non-gray area, and regulators might get very upset. Whereas, if the compassionate program press is accurate and not disputed by the data, I suppose it’s possible regulators understand the pragmatic temporary solution to keep this going.
The real problem is that peer review journal publication is taking too long. We don’t know who is holding this up. Everyone states it can’t be them, but in reality, just like congress can sometimes be held up by one anonymous congressman silently balking, just about any stakeholder could be the bottleneck.
So patients must make health and financial decisions without sufficient information in order to hopefully get to sufficient information, it appears.
This is clearly not ideal, however, open manual manufacturing is not ideal either. Automated closed system manufacturing seems more and more like how commercial (if approved) will start. This massive exponential production capacity could quickly encircle the globe.
Patients are caught in the horns of a dilemma, and the only real way around that is peer reviewed information, which is as yet unavailable.
