As recently reported by the Company, the FDA has granted the Company’s Type C meeting request to obtain agreement on the revised protocol endpoints for the Company’s Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The goal date for the FDA to provide its written responses is March 7, 2023.
TYPE C Meeting..............When requesting a Type C meeting, Sponsors can request a written response to their questions rather than an in-person meeting, videoconference, or teleconference. A sponsor may request a face-to-face meeting, but the FDA may decide that only a written response is necessary.
Yes, written correspondence would equate to a "back and forth" between parties.
Some should learn to Read and Comprehend before posting laughably mindless comments. lololsss
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