[Source: PR USA] – Critical Outcome Technologies Inc. (COTI) (TSX VENTURE:COT) announced today that it received a favourable Pre-Investigational New Drug (pre-IND) gap analysis report from an independent team that reviewed its novel oncology drug candidate COTI-2. This represents an important milestone as the Company draws closer to a Phase 1 clinical trial.
This gap analysis is conducted prior to an initial meeting with the U.S. Food and Drug Administration (FDA) to identify potential deficiencies in the preclinical development program of a new chemical entity being considered for human clinical trials. A thorough analysis of the preclinical data package for COTI-2 by an independent team of scientific and regulatory consultants revealed no deficiencies in the COTI-2 program.
For more information: COTI-2 Receives Favourable Independent Pre-Investigational New Drug Gap Analysis Report