We've discussed this before - another trial will be required, with surrogate endpoints as per the AA.
Only a matter of time before we know if I'm right or wrong.
But the FDA agreeing to roll out an experimental wildly invasive procedure whose evidence is based on a trial that failed to meet primary endpoints is just absurd, IMO.
Time will tell.
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-61
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