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FDA Lifts Partial Clinical Hold on Phase 3 AIM2CERV Study of Axalimogene Filolisbac

Advaxis, Inc (ADXS)  More Company Research Source: Business Wire
Last advaxis, inc earnings: 3/12 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.advaxis.com
PDF PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that the U.S. Food and Drug Administration (FDA or Agency) has lifted the partial clinical hold on AIM2CERV, the company’s Phase 3 clinical trial of axalimogene filolisbac (AXAL) for the treatment of patients with high-risk locally advanced cervical cancer. In its letter, the FDA acknowledged that the company satisfactorily addressed all hold questions. As announced on January 23, 2019, the FDA placed a partial clinical hold on this study relating to the Agency’s requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The Agency did not cite any safety issues related to the trial and all enrolled patients continued to receive treatment, per [Read more]

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