Ayala Pharmaceuticals Inc (ADXS)

[Traderbx]

ADXS 10K from Tony 12/21/17

EU Submission:
Progress to date towards submission of the filing includes axalimogene filolisbac’s designation as an ATMP, certification of quality and non-clinical data by the CAT, CHMP confirmation of eligibility for Union Marketing Authorization, assignment of EU rapporteurs, and pre-submission meetings held with the rapporteurs. Feedback from the rapporteurs advising the provision of additional clinical information in the submission package led to a delay of the filing which is now planned for Q1 2018. Once the package is submitted, the CHMP review process is expected to take approximately 13 months, and the Company plans to provide an update at the end of the review.