Biotech Values

[DewDiligence]

ADXS—FDA acknowledges that patient death not drug-related:

http://finance.yahoo.com/news/advaxis-provides-additional-information-clinical-210500638.html

…the FDA has concurred with the Investigator’s assessment that the patient’s cause of death, in the safety report triggering the clinical hold, was due to cervical cancer progression.

While no additional safety concerns have been identified by the Agency, it also verbally notified the Company that the clinical hold included the INDs for ADXS-PSA and ADXS-HER2 so that their evaluation, and any mitigation measures, could be simultaneously applied to all product candidates.

Advaxis is continuing to work with the FDA to facilitate review and resolution of this matter. The Company expects that the clinical hold will be resolved without significant interruption to its clinical development programs.

ADXS previously told investors that the clinical hold pertained to only the ADXS-HPV program, but it evidently includes the HER2 program as well. Still, this announcement is very good news overall.