Great post Umibe. I’ve said this before; the FDA is not some vindictive punisher for not having foreseen issues that have never been an issue. PFS has been a controversial endpoint despite how often it’s been used in Cancer trials. Scientists love to fuck with one another in some intellectual bullshit sparring match and it’s all ego. If someone looked like they had progressed on DCVax and afterward ‘everyone appears to be living longer than expected’ (Dr. Liau) and subsequent MRIs show the “recurrence” has now cleared then it was not progression in the first place. Nothing else matters. That is NOT a “failure” of PFS no matter how someone wants to spin that. No one in their right mind, including the FDA, is going to dismiss reality and claim that ‘well, you counted it as a PFS event so we have to keep it at that’… and “fuck you”. That is not going to happen. Period. PFS is meant to be a marker so that a trial doesn’t have to go on for 12 years for OS, so PFS is insignificant at this stage. One needs no “marker” of survival if the survival itself is produced. However, the SAP more than likely used the marker of “confirmed progression” as a way to back up the efficacy because it was so long, and to avoid detractors claiming it was all just coincidence somehow. Wall Street can be fooled by such bunk, scientists and clinicians not so much. And as you imply, it’s us clinicians that matter the most in the end market. I believe NWBO has the home run, know it, and are in no hurry to allow a single crack to develop and leave an opening for the obvious bullshit that will flow once TLD is announced. Look no further than the last 2 years with COVID; once the crap hits the internet the conspiracy is on…
