Sep 19, 2019 / 06:30AM GMT
Keita Mori - SanBio Company Limited - Co-Founder, President, Executive Officer & Representative Director
Hello again. This is Keita Mori from SanBio, and thanks for this opportunity to provide the update 2x a year basis.
So today, I will go over these financial results of the second quarter of this fiscal year. Before we -- before I start talking the updates, first of all, I'd like to provide you with the latest, latest exciting updates that we just announced earlier today. This is -- we have recently obtained RMAT designation. This is Regenerative Medicine Advanced Therapy designation from the Food and Drug Administration in the United States. This is similar to a Breakthrough Therapy designation, which is -- which has all the benefits and acceleration potential for drug approval, and this RMAT is even better than Breakthrough Therapy designation.
So this year, as I look back earlier this year, we've got the Sakigake Designation from PMDA in Japan. Just lately, we got the RMAT designation from the FDA. This is a reflection of the, I think, a strong interest and endorsement from
Q2 2019 SanBio Co Ltd Earnings Call Transcript
Sep 19, 2019
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