InvestorsHub Logo
Followers 5
Posts 1278
Boards Moderated 0
Alias Born 04/15/2019

Re: None

Saturday, 04/24/2021 3:05:04 AM

Saturday, April 24, 2021 3:05:04 AM

Post# of 7485

I mentioned our three pivotal clinical trials earlier and we are working toward our goal of having our vitiligo product approved and on the market in calendar 2023 with our soft tissue or trauma indication to follow in 2024.



Does anyone have any new info about Japan approval. This is the most recent thing I could find. It's from February:

We continue to seek approval in Japan. As previously reported, we completed the three required non clinical bench top studies in August of 2020 as scheduled. Our efforts and interactions with COSMOTEC and the Japanese Regulatory Authority are ongoing. But at this time, due to the broad labeling applied for. I do not have an update on when we might advance our application for marketing approval of the RECELL system under Japan's pharmaceutical and medical devices Act, or PMDA.

I could have sworn that I read an article stating that it would happen around H1 of this year.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent RCEL News