I think we all need to realize that if others, including UCLA, are running trials with DCVax-L, whether it's made by the company, or produced by the sponsor, with NWBO's okay, it's the sponsor of the trial who'll discuss results. If as UCLA has done they specify their dendritic vaccine is DCVax-L, once results have been officially presented by the sponsor, then NWBO can discuss them. It would be different if NWBO was listed as a sponsor, or co-sponsor of the trial, but that doesn't appear to be the case in either the trial in Germany, or recently disclosed here, and it's certainly not the case in the UCLA sponsored trial. It was the case for the Phase 3 Trial for DCVax-L.
It should be noted that Merck also isn't listed as a sponsor in the trials utilizing Keytruda. I would expect as either registrational Phase 2's or Phase 3 Trials begin, all companies who's products are considered a part of the trial should be co-sponsors in such trials which ought to be done at multiple clinical sites. Given their experience I'd not be surprised to find that UCLA was the lead clinical site, and with her working relationship with NWBO, I'd be surprised if Dr. Liau was announced as the lead clinician. In fact, if the trial is aimed at one or more other solid cancers, the lead clinician could be from an entirely different department.
It's my belief that any new registrational or pivotal trial will take at least a few years to arrive at a conclusion with an exception of having the DSMB halting early for efficacy, recommending early approval, or futility, trial failure. If anecdotal evidence is strong, the trial may not be necessary for patients getting the drug, off label use will be permitted and covered by insurance if sufficient data exists to justify it. I've never seen precise figures, but it sounded like over 100 in the compassionate use program in the UK used DCVax-L for a variety of solid cancers. That's a fair amount of anecdotal evidence.
Gary
