Great minds. In this instance they can say even “confoundment”, but then letting the trial continue would be unethical if it was just that, but the reality of allowing the trial to continue says to me that they know what they can’t say, that if it continues to perform so well, they will still have to approve for a rare disease. I am very much optimistic because of the way the regulators have behaved from the MHRA to the FDA all the way along. People can be pessimistic and presume all kinds of things but the reality of many details suggests more positivity than not, and then you have the significant results and the seeming to bend over backwards to accommodate the trial and company. They want a win with GBM and I think they honestly believe it is shown by the evidence. It just all needs to be laid out with manufacturing and other aspects that are also critical.
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