It's all good and still definitely in the pipeline. Just delayed.
The July update mentioned that there were delays due to COVID-19. In addition to COVID, they said in July that the PMDA (Japans FDA) had asked for some extra studies). Avita undertook three non-clinical or “benchtop” tests. Those were completed and submitted to the PMDA prior to the November AGM this year and now it's an approvals waiting game. It sounds to me that they are back on track.
July update
Progress on the application has been delayed due to the COVID-19 pandemic and the associated State of Emergency declaration in Japan. In addition, Japan’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), has now requested various non-clinical “raw data” (e.g., original hand written copies of data entry forms or records) of a small subset of our historic studies, some of which were conducted more than ten (10) years ago. To facilitate PDMA’s request, AVITA Therapeutics is repeating three (3) non-clinical or “benchtop” tests. These tests are expected to be completed and submitted in August, and the Company hopes to then advance our application for approval of the RECELL System in Japan.
https://ir.avitamedical.com/news-releases/news-release-details/avita-therapeutics-provides-company-update-and-preliminary
November AGM Transcript
Together with our commercial partner COSMOTEC, we continue to focus on regulatory approval in Japan. I am pleased to confirm that we have completed the three required non-clinical benchtop studies in August as scheduled. Our efforts and interaction with COSMOTEC and the Japanese regulatory authority are ongoing. And we are hopeful of advancing our application for marketing approval of the RECELL System under Japan's Pharmaceuticals and Medical Devices Act, or PMDA.
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