The date of the presentation you are showing was shortly after the screening halt. The enrollment continued after that date. You think the total enrolled is closer to 300, I think it is closer to 348, who knows the final number.
We do know the FDA has taken a fresh, more aggressive stance toward oncology clinical studies and drug development in the hopes of collapsing the decade long period of studies that has occurred in the past. This has resulted in more aggressive FDA actions to facilitate submissions and approvals. And, a rolling submission is mostly at the discretion of the agency (disease/therapy dependent), regardless of whether or not a designation has been assigned. And, a company does not have to divulge if they are engaged in a rolling submission as this is a regulatory dialogue process. An NDA or BLA is a significant undertaking no doubt, take considerable resources, and, are typically well planned well in advance (process, info and data requirements and resources) of the initiation of document collection/collation. Yes, this will be a full BLA and not a supplement. I do not know whether the FDA will convene a panel prior to their decision or not, dendritic cell therapy has already been approved once, but, it is up to them to decide. I do not know whether there is a rolling submission occurring, but, the circumstances do fit the possibility, when the company stresses continual dialogue with regulatory bodies. If the data is strong enough you would have to logically conclude something very positive is occurring. If the data is not that convincing, maybe not. 30% long tails will raise FDA reviewers eyebrows quickly.
You of course chose not to mention the CEO's statement about good news being presented as bad news by some in the bogus basher press.
It will always be far easier to tear down than to create. Hopefully, and, yes there is hope here as with all worthwhile endeavors, hard work and hope has to be applied, this therapy is successful, and, NWBO is currently getting closer to a significant step.
What is fact is that the P3 study has not lost time regardless, as long as the enrollment continued and achieved a sufficient number of patients, which I believe to be true. Obviously I will fit some facts in the way I believe is valid, you are entitled to do the same. I am very hopeful here for the creation of something good, and realize there is no guarantee, but, I see the puzzle fitting well together and am willing to invest accordingly.
