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Re: jesster64 post# 674486

Saturday, 02/24/2024 11:24:16 PM

Saturday, February 24, 2024 11:24:16 PM

Post# of 721705
I would say the prediction that it will not be approved based on the P3 trial is solid.

. Trial failed designed primary endpoint

. IA performed that would be expected to call a futility halt on the above.

. FDA halts further patient enrollment.

. Trial continues (as is legit) hoping for OS.

. Trial blows past defined OS endpoint comparing 232 vs 99 with company now saying waiting for more events.

. Presto, randomized trial changed to a comp vs ECAs.

. OS between those on treatment(232) vs placebo (99) never disclosed despite still being an endpoint

Anybody who expects this cluster F to be approved need to invest in some other space.

BTW, will post later on the extent of resection problem. That is a huge issue for those who deny real problems exist.
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