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FDA Grants Special Protocol Assessment to Advaxis’ Phase 3 Study of AXAL in Patients with Cervical Cancer

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Management Comment
“Collaborative discussions with the FDA led to a positive outcome with a SPA that clearly defines the clinical and regulatory pathway for the approval and commercialization of AXAL for the treatment of patients with HRLACC,” said Daniel J. O’Connor, President and Chief Executive Officer. “Obtaining a SPA for the AIM2CERV Phase 3 protocol was our number one priority this year and it has now been achieved.”
http://ir.advaxis.co...
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Catalyst Date
Occurred on:
Jul 06, 2016
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Related Keywords Cervical Cancer, Axal, Phase 3 Aim2cerv Trial, Lm Immunotherapy Candidate, Axalimogene Filolisbac, Aim2cerv, Listeria Monocytogenes