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Monday, 12/28/2020 10:20:32 AM

Monday, December 28, 2020 10:20:32 AM

Post# of 704590
Sunday, 12/27/20 10:49:22 PM
Re: flipper44 post# 342740 0
BRILLIANT FIND:





Post #
342862
of 342949
Dr. Liau March 17, 2020
https://billmalloy.info/qa-with-linda-liau/
Quote:
So, a part of it is having the FDA think a little bit differently about what constitutes approval. On the converse, like the Optune device, that Novocure device, is FDA-approved. But I must say a lot of patients are like, “Well, I don’t really like it.” And I think on the physician side, we just don’t understand how it works and there are a lot of problems with the clinical trial design.

There was no true placebo arm, but they did design it in a way that met the FDA checkboxes. So, it was approved, but a lot of us don’t really believe that it works. I think it’s one of these things where if your ultimate goal is to cure GBM, it’s hard to reconcile all these different factors; the regulatory factors, the financial factors, as well as the science and the biology of the tumor itself, which is very complex.

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