10:09 AM EST - BioVaxys Technology Corp. : Announced today that the US Food and Drug Administration ("FDA") has provided its official Written Response to the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2. The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys' clinical development plans for CoviDTH. In addition, the FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study. Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study. BioVaxys Technology Corp.
shares C.BIOV are trading up 6 cents at $0.29.
