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Re: skitahoe post# 454932

Tuesday, 03/29/2022 12:46:37 AM

Tuesday, March 29, 2022 12:46:37 AM

Post# of 698574
They are not rules, they are laws Gary. Democratically run countries don't have their regulatory agencies breaking laws. That leads to chaos and outright, clear cut, corruption. The kind you see in countries without a history of having laws that are followed at all.

They can end trials early when they fit a very specific story. If they do not fit that story, they can't end them.

As for outperforming SOC, no, that's only true if you look beyond the actual trial. They have permission to follow rules and deliver data that will prove that, but it's not apparent only from the data in the trial. There is no placebo arm adequate to prove that point. There are rules, and laws and ways you can get things done and ways you can't. The rules are being rewritten to make it easier for trials to address issues, and this trial is benefitting from some of those new changes. But they don't just declare a drug approved by fiat.

Gleevec's trial was not like this trial, and they did not have the same issues. Cell therapies are also and have been treated as a particularly complex area.



I know they have rules, but there are times they should break them.

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