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How LTR Pharma’s Safety Study Completion Advances SPONTAN’s FDA Journey
8:50am on Monday 30th of June, 2025 AEST
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Pharmaceuticals
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How LTR Pharma’s Safety Study Completion Advances SPONTAN’s FDA Journey
8:50am on Monday 30th of June, 2025 AEST
Key Points
Extractables study for SPONTAN completed with all compounds below ICH safety thresholds
Leachables study commenced under real-world storage conditions
Studies critical for FDA 505(b)(2) regulatory submission
Partnership with Aptar Pharma supports device and regulatory expertise
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