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June 10, 2014
06:32 EDTADXSAdvaxis says End-of-Phase 2 meeting with FDA has been granted to review ADXS-HPV
Advaxis announced that its request for an End-of-Phase 2 meeting with the FDA has been granted. The purpose of the EOP2 meeting with FDA is to review clinical findings to date of Advaxis's immunotherapy product candidate, ADXS-HPV, in order to assess any additional information needed prior to moving ADXS-HPV forward with the next phase of its clinical development. The meeting will establish a dialogue with FDA on ADXS-HPV during which Advaxis can obtain agency recommendations and feedback on the next steps it needs to take in investigating this important immunotherapy product candidate. Advaxis plans to prepare and provide FDA with a comprehensive package detailing its investigational invasive cervical cancer therapy, its phase 1 and 2 clinical findings, its CMC strategy and the Company's plans for a pivotal phase 3 program.
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