On June 9, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application (BLA) (Press release, Abeona Therapeutics, JUN 9, 2023, View Source [SID1234632583]).

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"Gaining alignment with the FDA on the RVV comparability package is a very important de-risking milestone for our BLA submission after our recent successful completion of the Process Performance Qualification (PPQ) manufacturing validation runs," said Vish Seshadri, Chief Executive Officer of Abeona.

As part of the package, the FDA requested additional assay data to establish comparability between RVV sourced from Indiana University and RVV manufactured in-house at Abeona, both of which have been used in the EB-101 clinical studies. The Company has the necessary reagents in-house to promptly generate the requested data. To allow the FDA the necessary time to review the requested RVV data, Abeona has requested that its pre-BLA meeting date for EB-101 be rescheduled for August 2023. The Company expects to file its BLA for EB-101 in the third quarter of 2023.