Commercial StrategyThe planned digital-forward, partnered commercial strategy is focused on reaching high decile primary care physicians and one-quarter of the smoking population that is actively seeking to quit.
FDA Approval ProcessA successful outcome was achieved at the end-of-Phase 2 meeting with the FDA, aligning on a single P3 study to support a future supplemental NDA for vaping cessation.
LeadershipMark Oki assumes the role of CFO, bringing over 25 years of experience in financial leadership positions within the biotechnology and pharmaceutical industries.
NDA SubmissionThe ORCA-OL long-term exposure study required for the NDA (new drug application) is progressing as planned, and the initial phase was completed, allowing the company to move forward with its NDA submission.