Thursday, December 21, 2023 3:06:15 PM
I asserted they had an efficacy IA in 2015 We now know that is fact.
I asserted that the IA pointed to the PFS primary endpoint as being being futile. We now know as a fact that the endpoint failed badly.
I assert that the OS 232 vs 99 failed badly. Anybody who can not see that is clueless.
I assert the FDA guidance on ECA reads poorly for the -L submission. I stand by that
I assert the FDA guidance on tissue agnostic does not apply to -L. I stand by that
I asserted that they would not be approved based on this trial. I stand by that.
I never asserted they could not reach data lock, could not submit a MAA.
Come on druggie, argue facts, not BS.,
Ar you going to be like Steve (hoffman) and call me out on a few spelling errors and one quickly correctly post? Come on druggie, prove it.
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