Just an overview of the FDA discussion..."During the discussion, the company noted the results of its clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed both non-inferiority and superiority for time to hemostasis using CelluSTAT (fka HemoStyp) relative to the standard of care and showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. UHP also noted that none of the adverse events that occurred during the study were attributable to its hemostatic gauze product. "

Hopefully the FDA can bring a new different approach with the coming Trump administration and new FDA leadership!! Sure seems to be some unfounded bias!!
$5-$10+