I'm just trying to get my head around what the timeline might look like now. Please me know if I have interpreted anything incorrectly or if you think this doesn't make sense:
Spontan FDA Approval - Q1 2025: FDA Pre-Submission Meeting (DONE) - Q2 2025: Animal Toxicology Study (was H1 2025) - Q3 2025: IND Application Submission (6 Months after meeting) (was H2 2025) - Q4 2025: Multi-dose pharmacokinetic (PK) study (25 subjects) - Q1 2026: Type C FDA Meeting (Development Milestone Meeting) - Q2-3 2026: Pivotal safety and efficacy trial (100-200 subjects) - Q4 2026: Prepare & Submit NDA - Q3 2027: FDA Approval (10 months from submission)
These activities run in parallel to much of the above and are not on the critical path: - Extractables & Leachables (E&L) Studies (with Aptar) - Human Factors Study (with Aptar) - Chemistry, Manufacturing, and Controls (CMC) plan
LTP Price at posting:
47.5¢ Sentiment: None Disclosure: Not Held
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