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SmileyRiley_595

09/01/20 9:57 AM

#113043 RE: KobeF #113041

There’s no twisting of facts! The primary endpoint demonstrated clinical significance and NEWS2 secondary endpoint demonstrated statistical significance. Both of these markers would warrant a phase 3 trial on their own merits. The FDA authorized SOC shamdesivir didn’t meet its original primary endpoint in a phase 3 trial so they changed it to “trend towards” a positive result... So, are you trying to say it does or, that it doesn’t matter? I would venture to guess any doctor you come across would indicate a statistically significant NEWS2 result in any trial would be of interest!

hopester

09/01/20 9:59 AM

#113044 RE: KobeF #113041

Let's see how they wiggle out of it when asked at the CC.
If the drug didn't work it's TAPs for them.