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Horseb4CarT

08/05/20 8:01 PM

#298594 RE: alexander77 #298568

Thanks for the info!

exwannabe

08/06/20 3:24 PM

#298692 RE: alexander77 #298568

They recently sent a SAP to change the primary endpoint into somerhing that has a better correlation with immunotherapy, which is the long tail OS curve.


And you know this how?

All we know is that they were working on modifying the SAP and had a draft complete. Then they went dark.

Why would they make a big todo about working on a SAP. And announcing they completed a draft. But not announce they actually submitted the IND modification?

Wonder if the FDA said they should not change the trial endpoints after a DSMB recommendation (of any form). Or even after whatever the FDA told them in 2015?

Nah, they just announce minor details but keep the big items quiet to trick the shorts.