The markets disagree, based on the share price, leadership's silence, and inability to raise significant capital, institutional investors are saying it is not pivotal and likely will not be supported by the FDA. It seems to have been reduced to a on again-off again study paid for by shareholders to the benefit of academia/hospitals.
Just being a P3 does not make it pivotal. There are requirements very well likely not met:
" Typically a Phase 3 study which presents the data required by a regulatory agency to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind."
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