audiobookprisonstories
Oct 4, 12:13 AM
$HUMA :I see a potentially major rerating opportunity as Humacyte approaches the dialysis sBLA. The global AV-access market has been estimated at ~
$6.5B, with the initial high-risk target population potentially representing ~
$3.25B of annual opportunity based on historical company assumptions. The roadmap is November 2026 sBLA filing, potential FDA acceptance around January 2027, and a possible May 2027 PDUFA if Priority Review is granted. Based on the Phase 3 V007/V012 data, >1,000 patient-years of dialysis exposure, and positive KOL feedback, I personally give the dialysis application an 85% chance of approval—my estimate, not a guarantee. I believe the market could increasingly price in approval before the actual FDA decision. The major risk is funding: HUMA needs sufficient cash to reach May, so I expect volatility, potential dilution, and trading swings along the way. If approved, even modest market share could create significant revenue potential, with additional upside from..
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