Fosco_
$IMMX Looked at who Immix has actually hired for the BLA. Stronger than the deck lets on.
* Karin McIntosh, SVP Head of Regulatory, joined October 2026. Came from Orca Bio where she delivered the TREGZI priority review BLA, ran every FDA meeting including pre-BLA, CMC potency and facilities, and prepared the site for PAI through mock inspections. Fifteen years in Regulatory CMC before that at Stemline, PTC, Merck and Pfizer.
* Oleg Evgrafov, Head of Quality, joined August 2025. Came off a BLA submission, FDA acceptance and a completed pre-license inspection at Capricor.
* David He on Technical Ops ran the CMC org that got equecabtagene approved at IASO, a BCMA CAR-T, and before that built Legend's TechOps from zero through cilta-cel site qualification.
Between their two BCMA CAR-T approvals and two completed PAIs, they’ve built a leadership team that leaves nothing to chance, ensuring investors peace of mind over the road to approval.
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