Abeona Therapeutics Announced Regulatory Update On Biologics License Application For EB-101; Said FDA Requested Additional Assay Data To Establish Comparability Between RVV Sourced From Indiana University, RVV Manufactured In-house At Abeona
Portfolio Pulse from Charles Gross
Abeona Therapeutics announced that the FDA has requested additional assay data to establish comparability between RVV sourced from Indiana University and RVV manufactured in-house at Abeona for their Biologics License Application for EB-101.
June 09, 2023 | 11:34 am
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Abeona Therapeutics' stock may be impacted by the FDA's request for additional assay data to establish comparability between RVV sources for their EB-101 Biologics License Application.
The FDA's request for additional assay data may cause delays in the approval process for Abeona Therapeutics' EB-101 Biologics License Application. This could negatively impact the company's stock price in the short term as investors may perceive this as a setback.
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