IF the MOA is validated via ongoing trials, then PPHM won't have to worry about the street questioning phase 3 data, because it will be moot as BAVI will have been approved.
The only question right now is BAVI the cause of the immune system response that PPHM has proposed as the MOA?
IMHO, PPHM knows the answer to this question because they have data/information from "tainted" trial, as well as getting blood and probably biopsy data from ongoing open-label trials. When those changes are happening in patients taking BAVI, but not occuring in control patients, well, there you have it.
Then the DMC for the SUNRISE trial can see the same things happening and all will be good in PPHM land.
JBAIN
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