The company has collected a citizen petition stating that PICO is second-in-class compared to Kalypto’s first-in-class NPD, although Kalypto’s attorneys have said that they don’t know specifics of Smith & Nephew’s clearance submission.
Kalypto has asked the FDA to ensure a thorough review of Smith & Nephew’s process, standards and performance data, including that PICO is compared to NPD.
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