George,
I believe there is more to it than that, but it occurred prior to my investing, so I'm basing what I'm saying on what I gather had occurred. To begin with, when the trial was temporarily halted I believe a number of things occurred.
I believe by that time they recognized that pseudoprogression was occurring and would render PFS a poor goal, at best. I believe they had discussions with the regulators, and the German's clearly seeing survival improvements insisted that all entering the trial should get the vaccine, no more crossing over when progression or pseudoprogression was seen. This decision was certainly more ethical, but I think it was jointly made by the company, regulators, and clinicians and had the agreement of the DSMB. As far as I'm concerned, I believe that if the regulators truly wanted to act in a dynamic way, they could have approved the vaccine then and there.
The decisions made during the halt led to extending the trial with Overall Survival becoming the goal and looking at it when the last patient entering the trial had 5 years. During the extended time it was up to the company to reach a common agreement with the regulators and produce a new SAP that all agreed on, this took longer than anticipated. Covid no doubt delayed many things happen in a timely way and couldn't be controlled by the company.
This trial is virtually causing regulators to re-write the books when it comes to how such trials are to be done. I suspect that in the future few trials against deadly diseases will use control groups, all who volunteer will get the experimental product and they'll be compared with historical data. I'm not suggesting we're the only reason for this, but certainly one of them.
I'm no fan of the regulators, I think they're very slow to move, but that said, I do believe they've made the right moves in the trial, even if it took much longer than I'd like. I do believe all four will approve DCVax-L and the last approval will come in less than a year after the first approval.
No matter how much we learn about what happened during the trial, all sorts of questions will never be answered. That's not just the case here, it's the case in practically every trial that's ever been run. In the end, we'll be happy with the bottom line as either we'll be a high flying biotech, or we'll be acquired at a price we'll be very happy with. My guess is we'll know what direction we're going before 2024.
Others who were investors for years longer than me can probably paint a better picture of what's happened, but that's my view of it.
Gary
