InvestorsHub Logo

exwannabe

09/13/21 3:59 PM

#401778 RE: CrashOverride #401770

As Linda Liau stated at Mt Sinai, historical controls should be used


LL was saying that designing trials to use historical control groups would be good.

That is not the same as saying a trial that was already run as a RCT should discard that an instead dig of historical controls.

Maverick0408

09/13/21 4:27 PM

#401792 RE: CrashOverride #401770

UK & EU accepted it last year. FDA has not been easy to convince one way or another and LL alluded to this last year, I think. My sense is a top notch peer reviewed pub, updated WHO GBM definition, and UK approvals will do the trick for FDA officials eventually as well. I think NWBO management is handling this very tactfully! And LL is fully supportive of this strategy and is persistent by nature. Won’t take no for an answer!