Jan. 16 at 10:43 PM
$RVPH Summary of Information provided by Dr Bhat at the recent Lytham Partners conference.
Regulatory update:
~ FDA reviewed the full dataset at a pre-NDA meeting.
~ No negative comments on existing data.
~ FDA recommended one additional Phase 3 trial to support an NDA.
~ Reviva plans to start the new trial in early Q2 2026, complete it mid-2027, and submit an NDA in Q4 2027.
Financial update:
~
$12M cash on hand.
~
$50M additional capital required to complete the trial and NDA.
~ Management expects to provide financing updates within the next couple of weeks.