Lachlan's questions to Lyra Therapeutics (LYRA) leadership • Q1 2021
Question
Lachlan from William Blair asked about the key gating factors for initiating the Phase 3 trial beyond the FDA meeting, specifically regarding product validation from the CMO. He also inquired about plans for regulatory discussions outside the US for the Phase 3 design.
Answer
President and CEO Maria Palasis identified the final protocol submission to the FDA and delivering the clinical product to trial sites as the critical gating items, expressing confidence in the timeline. She stated that the immediate regulatory focus is on the US for the trial, although the company is actively pursuing ex-US partnerships for commercialization. CFO Don Elsey also reiterated that the financial guidance covers the planned Phase 3 and Phase 2 trials.