On April 17, 2025, Dr. Laura Niklason, President and CEO of Humacyte, Inc., issued a statement addressing a recent 'citizen petition' filed with the FDA and what she described as 'unsubstantiated attacks' by detractors. Niklason asserted that the petition's signatories, who have not used Symvess, aim to halt the company's progress.
She highlighted that one signatory, Hooman Noorchashm, has filed nine previous petitions with the FDA without agency action. Niklason also pointed out that the company's chief critic, Robert E. Lee, left the FDA before Symvess was approved and co-founded a consulting firm whose leaders advise a potential competitor, Phraxis, Inc.
Niklason stated that the 'citizen petition' is without merit and that Humacyte will respond to the FDA at the appropriate time. She emphasized the company's two decades of work and its commitment to the safety and effectiveness of Symvess, which has treated over 600 patients in 9 clinical studies without safety halts.
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