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Given that the CHF LVAD 2b trial is RMAT designated. If the results are 'good' it is possible to go directly to accelerated approval with phase 3 trials to follow up.

E.Accelerated Approval

As explained in the Expedited Programs Guidance (Ref. 1), accelerated approval has been used primarily in settings in which the disease course is long and an extended period of time would be required to measure the intended clinical benefit of a drug. Section 506(c) of the FD&C Act provides that FDA may grant accelerated approval to drugs,9which include regenerative medicine therapies, that treat serious conditions, provide a meaningful therapeutic advantage over available therapies, and demonstrate an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit, or (2) a clinical endpoint that can be measured earlier than irreversible morbidity and mortality that is reasonably likely to predict an effect on irreversible morbidity and mortality or other clinical benefit (i.e., an intermediate clinical endpoint). Sponsors of drugs that have been granted accelerated approval have been required to conduct post-approval confirmatory studies to verify and describe the anticipated effects of their products on irreversible morbidity and mortality or other clinical benefit (Ref. 1).