One has to be an incredible dirtbag to avoid submitting a BLA and sitting on a cure for GBM for an extra year plus while patients are dying every day just to synchronize TLD release with a journal publication.
Nonsensical assumption that no progress is being made towards BLA while the public waits for TLD/publication.
No thats not how trials work? So you are asserting Biotech’s can do whatever the hell they want without consulting with the FDA? You need to do some reading upon the basics of how biotechs work, because that is exactly how trials operate.
Then you start a whole new discussion about the DMC which should have halted on IA blabla for reasons of efficiency blabla which has nothing todo with my response to Ex his posts and B. is a completely different discussion and has been discussed here about a million times.
Hint halting the trial would not have delivered the big fat golden standard OS LP wanted and with good reasons and would have come when they had not been able to submit the amended SAP yet and thus sabotaged the amended SAP..
That's not how trials work. If the treatment worked per the DMC during the IA, the DMC would have recommended the trial be halted for efficacy, the company would have unblinded and submitted a BLA (back in 2016).
That my understanding of how it works. Procedurally this brings, new, promising treatments to patients faster. A win for the companies, and a win for the patients. 5+ years later no TLD.
I am not saying that DCVAX L does not work. But it is tragic that this treatment is not now available.