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BIOFILM PICTURED AS LIKELY CULPRIT, THOUGH PATIENT DIED OF CANCER

Listeria mystery: Uprooting implanted doubt, Advaxis persuades FDA to lift clinical delays

By Randy Osborne
Staff Writer

Wednesday, December 16, 2015

Calming FDA qualms by way of trial changes, Advaxis Inc. reached an agreement with regulators to lift the clinical hold on three compounds and Wall Street responded nicely, sending shares (NASDAQ:ADXS) to a closing price Wednesday of $10.92, up $2.62, or 31.5 percent. CEO Daniel O'Connor told BioWorld Today that, after talks with the agency, the firm has agreed to implement risk mitigation measures such as study protocol inclusion/exclusion criteria, post-administration antibiotic treatment and patient surveillance measures, though he declined to go into detail.

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