Here are some more details on future plans from their most recent update that highlight what the next 6-12 months could look like:
- Japan's regulatory body PDMA has requested Avita for a subset of non-clinical raw data from 10 years ago, In August AVITA will repeat some tests and and the Company hopes to then advance their application for approval of the RECELL System in Japan.
- The pediatric scales tests that started pre covid have been paused and are expected to resume later in the year
- In July 2020, FDA approved their IDE application for the pivotal study which is titled “A Prospective Multi-Arm Blinded-Evaluator Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo.” The Company expects to commence enrollment in the vitiligo pivotal study in the second half of this calendar year.
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