Santen Pharmaceutical Co., Ltd.
Q1 2022 Earnings Call Transcript

Published: 7 Aug 2022

[Peter Sallstig:]

Thank you very much. Good afternoon. I'm Peter Sallstig, Chief Medical Officer. I would like to report the status of pipeline, please see Page 20. On the R&D front for the first quarter, we continued to progress in our pipeline. As you can see, we have nine projects in the late phase, coupled with development in new areas

[A - Peter Sallstig:]

This is Peter Sallstig, Chief Medical Officer. Thank you for the question. What we can say for certainty at this stage is that we are looking into options to move forward as expeditiously as possible not only in Japan, but also as you have seen, we started here the preparations now also for our Phase 1 in China. While I can't go into more specifics with regards to the timelines, what again I can confirm is we're looking forward to moving this forward as quickly as possible here in Japan. Thank you.

[Peter Sallstig:]

This is Peter Sallstig, Chief Medical Officer. In the complete response letter from the FDA that we received, the issue of non-compliance with regards to the contract manufacturing was clearly mentioned. We have been working together with the agency, with the contract manufacturing to ensure that we're able to address all their requirements. We resubmitted this on May 6. We got the agreement that we had appropriately addressed the requirements in order for them to start the in-depth review and we are looking forward to receiving the PDUFA date by November 6 the latest. Thank you.