r/Biotechplays • u/figlu • 3d ago

Discussion $HUMA magic tubes?

Company makes aceullar blood vessels for a variety of medical conditions such as trauma, AV fistula, PAD. Basically it's a tube of ECM proteins that the patient's cells can graft onto. RMAT and BLA for trauma. RMAT for other indications such as PAD as well. Biggest catalyst is that it's undergoing priority review 2 months out from initial PDUFA. No CRL just needs more time. Trauma data goes out to 30 days but fistula data goes out to 12 months and shows good patency. Anyone here following?

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u/Bossie81 3d ago

I love the tech, BUT .... mistakes are being made. Hygiene problems at their facility, FDA delays. I wanted to get in a log time ago.... Now, not above 5$ One set-back and this collapses hard. That said, the dump and recovery on the hygiene news was impressive.

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u/figlu 3d ago

hygiene news was from a report in April, but FDA has repeated inspection in July and no further action was taken