Doc,
I realize that normally a BLA would be required; however, if under Orbis the FDA told the company to file with the UK and all countries involved in Orbis would work with that filing, then I believe a BLA wouldn't be needed. Essentially, I'm saying the FDA told them it wouldn't be needed to keep the secrecy of working under Orbis in place.
I'm not saying that this is the case, I don't believe it is, but if the regulators wished to maintain secrecy in an Orbis filing, this would be one way of doing it.
My belief is that we're headed for approval with the UK. Once that occurs, I wouldn't be terribly surprised if Europe says, we'll accept the British opinion and approve it as well. Remember, when the trial began the UK was part of the European group of nations, their trial protocols appear to be pretty much identical. Canada, and perhaps other countries like Australia which are closely associated to the UK could also piggy-back on the UK approval with little to no work from the company. I don't know that the same may not be said for Mexico if given the opportunity to do so.
Years ago, I can remember US Citizens going to Mexico to get a drug being hyped down there for cancer based on peach pits, as I remember it. If DCVax-L were available in Mexico, I believe many US citizens would go there for it if it's not available here.
Everything starts with UK approval, I don't think it will be too much longer before we have it. I can't say if other things will take days, weeks, or months to announce, but I believe that once we have approval, many new announcements will be forthcoming.
Please remember, when I say I believe something is possible, I'm not saying I believe it will happen. In this case I'm saying if the FDA told NWBO to file with the UK under Orbis, then no BLA would be required.
Perhaps someday someone will write a book, or do a movie, about NWBO and how this trial changed the way many regulators operate or at least created new options. I do believe it was that revolutionary a trial. Think about it, if we never had pseudoprogression and the vaccine could be approved based on progression, I don't know that the changes suggested in the journal article written by the FDA staff may have ever been established. I don't think they've yet made the changes official, but I believe if a trial were submitted under the protocols suggested there, it would be accepted. No doubt pseudoprogression has cost the company time, and money, but I believe it's really changed the way many trials will be done in the future, even if it's of no concern in those trials.
The persistence of LP and the rest of the company could truly be a great story if someone were free to tell it. On the other hand, I suspect that much of the discussions with the regulators will never be told, and the story will largely be hidden forever.
Gary
Bullish
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