Vancouver, British Columbia, June 14th, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) (“BioVaxys”), is pleased to announce today that the US Food and Drug Administration (FDA) has reviewed its Pre-IND request for a Type B review of its CoviDTH program and has determined that a Written Response is sufficient to address the Company’s questions regarding bioproduction and clinical development plans for its planned pivotal Phase III study for its T-cell immune response diagnostic for SARS-CoV-2. The FDA has stated that the Written Response will be available by July 23, 2021.
BioVaxys submitted a Pre-IND meeting request and briefing package with the FDA’s Center for Biologics Evaluation and Research (CBER) for CoviDTH in March of this year. The Pre-IND review request is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, quality controls, etc.
The FDA has the option to not grant a Pre-IND review for substantive reasons such as it being premature for the stage of product development or not providing an adequate basis for the review.
Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated “We are pleased that our Pre-IND submission package was successful in presenting the rationale for CoviDTH and our development plans. The FDA review and response to our questions will dovetail with the in vivo animal safety study of CoviDTH that we are starting in July and ensure that we have the necessary information to file our IND.”