Clinical EfficacyThe NDA is supported by results from the Phase 3 pivotal trial where Anaphylm demonstrated rapid onset of action with exposure levels comparable to auto-injectors.
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' & drive meaningful expansion of the T1A market beyond current autoinjectors longer-term.
Regulatory ProgressFDA acceptance of the Anaphylm NDA submission is expected, and the advisory committee meeting process could highlight the potential benefits of Anaphylm for patients.