Just curious, but how many of those 50 to 60 trials involved novel biologics, in a hard to analyze skull, where similar countless treatments had failed, possibly because of novel reactions not well understood, that involved 1) an unexplained partial halt, 2) with incredible seeming results that simultaneously may have involved a muddling of a crossover placebo arm; 3) that involved incorporating a complex external historical and synthetic placebo concept; 4) persisted through two financial crises, one involving a global pandemic (during the data lock period) which killed more Americans in one year than any of our conflicts of war; 5) took 14 years, during which our understanding of the targeted disease, diagnostics, relevant biomarkers and immunotherapies, including pseudoprogression were radically affected and shaped; 6) did so on a shoe string; 7) was global, involving 4 regulators; and 8) did so in the context of such shifting notions in terms of cancer that one might want to collect additional data from tissue and archived tumors to establish a regulatory premise that the treatment might effectively be a general oncology drug, not just for tumors in a certain part of the body.
I do not know, but it feels like this is a bit of a unique trial, and that taking a longer time is not even likely to suggest failure, though it could obviously involve weaving a coherent, scientifically valid story to ensure approval of this novel treatment comes at the end of all of the management of these incredibly complex, multilayered circumstances and unavoidably massive and chaotic societal events. I do not blame those complexities on the company or researchers....they are trying to thread an incredible number of needles all at once, and do so carefully and thoughtfully, under incredibly nice circumstances.
Oh, and they simultaneously have to have a plan for and create a manufacturing system for a novel living product in a commercial fashion that enables financial success.
It does not seem like comparisons are necessarily going to be all that illustrative, no matter the number of trials one may have observed. It seems like jumping to conclusions would probably be not all that reasonable, especially given the crazy state of the world right now alone.
But everyone has an opinion, and many people think they know things, and experts are frequently wrong to a degree that is difficult to explain other than the fact that in many cases, observations of other circumstances are simply not comparable. Everyone has an opinion.
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