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NovAccess Global, Inc. Announces Successful Completion of Pre-IND Meeting with FDA ACCESSWIRE 30 Jun 2021, 06:05 GMT+10 CLEVELAND, OH / ACCESSWIRE / June 29, 2021 / NovAccess Global Inc. (OTC PINK:XSNX) announced today that it received a productive response from the U.S. Food and Drug Administration (FDA) on its pre-investigational new drug (IND) meeting request regarding the development plan for Glioblastoma Multiforme (GBM) patients, including the clinical study design and dosing strategy for the initial phase 1/phase 2 protocol. The FDA recommended conducting an initial Phase I trial to evaluate product feasibility, toxicity and activity arising from NovAccess Global s novel DC maturation procedures, but also provided specific current good manufacturing practice (cGMP) compliance guidance in the case that the Company proposes a Phase II or later stage clinical trial.

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