I think we should also remember, the combo trial is an rGBM trial, which makes a ton of sense initially.
If we go back to the comparative crap the FDA let through the door in years past, wherein survival was not improved on any level, (yeah, I’m talking about you Avastin), regulators need to, in my opinion, engage a “makeup call” for something that really really appears to work. Maybe God will let them off the hook when they reach the pearly gates. :-)
We will see how it plays out, Flip. Overall I agree with your thought process but I do not expect application to be submitted this month or next. This management has again not been transparent with shareholders as they have likely been holding off on the application for combo data to reach some level of maturity.
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