“Classification of AXAL as an ATMP is reflective of a groundbreaking new opportunity for the treatment of HPV-associated cancers,” said Robert Ashworth, PhD, Vice President, Regulatory Affairs. “Building upon the approach endorsed at Advaxis’ meetings with National Competent Authorities earlier this year, it allows us to take advantage of a specific EU regulatory framework, akin to fast-track in the United States, designed to facilitate the review, approval, and access of AXAL in the EU market.” In the next phase of this regulatory process, CAT assessment of currently available quality and non-clinical data may help resolve some issues prior to the submission of a marketing-authorization application (MAA).
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