Clinical Study ResultsAnaphylm was safe and well-tolerated in the pediatric study with no serious adverse events.
FDA Approval ProcessFDA acceptance of the Anaphylm NDA submission is expected, and the advisory committee meeting process could highlight the potential benefits of Anaphylm for patients.
Market PotentialThe T1A market should be large enough for multiple no-needle epi players including Anaphylm, and no-needle epi products should ultimately 'grow the pie' and drive meaningful expansion of the T1A market beyond current autoinjectors longer-term.