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Friday, August 26, 2022 12:29:28 PM
The key is they cannot be changed based on data from the trial.
Whatever they based the endpoint changes on, it’s done. The SAP is the cement that seals them in.
Anyhow, we hear all the time in our lives how something can’t be done, and then it still gets done. A rather perfect recent example is that a president cannot forgive a loan, only Congress. And then the president goes ahead and forgives loans anyway, and for some, that’s good; for others, maybe not so good. But that move certainly appears to be breaking the rules.
My point is that rules are broken all the time… sometimes for good reasons, sometimes for bad ones, and sometimes for no reason at all. And sometimes there are consequences, and sometimes there are not.
Finally, beyond the fact that the UK and the EU who control their clinical trial sites and are the ones in charges of changing the sites - which they did for the P3 endpoints; the recent company PR about the UK PIP indicates that the UK is fine with the ECAs and the methodology the company is using to assemble them as they have accepted them in the PIP trial. It stands to reason, then, that they will accept them in the P3 trial. So even if you think that a rule has been broken by switching the endpoints to ECAs, many would argue it’s a rule worth breaking as DCVax-L has a statistically significant record (with the ECAs) of helping GBM patients live longer… for both newly diagnosed and recurrent.
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