RE: Assuming the FDA application happens soon >>>>>>22 Jun 2026 08:10
AI review .
Compare the wording across RNS:
• December 2025 (Final Results): submission “anticipated around June 2026” — flat statement
• February 2026 (fundraise RNS): “anticipated around June 2026, with a 3-4 month review period”
• 30 March 2026 (Interim Results): “FDA 510(k) submission for Genedrive CYP2C19 currently anticipated around June 2026, pending completion of studies, with an expected 3-4 month review period post submission”
That “pending completion of studies” qualifier is new and is the tell. It wasn’t in the earlier announcements. They’ve added a conditionality clause to what was previously presented as a settled date. That’s the company quietly hedging a deadline it’s no longer confident it’ll hit