Mi D,
I've never said we don't need regulators, we just need them to act more dynamically and not cost trial sponsors so much time and money. It shouldn't take 15 years to determine this vaccine is a dramatic improvement on the SOC. It would have been easy to make that determination after about half the time but have all who received it after that report the outcome as a Phase 4 trial. Certainly a lot of those people would die, but 95% of them would have in 5 years or less, so they could see that less than 95% are dying and do it for very little cost.
This is far from the only trial I've seen that's taken over a decade. In one case, what was supposed to be a registrational Phase 2 was submitted to Dr. Padzur, he determined that he didn't like the format and refused to read it. There is little doubt the format was established with people in his staff, but the Phase 3 required for Kadcyla lasted a few years longer, but it was approved. I can't tell you if he, or an advisory committee would have said it ought to be approved in Phase 2, we'll never have a chance to know. There was never a complaint from Genentech as it's simply not wise to criticize the person who's responsible for judging your products.
Gary
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