development 스포츠 배팅 사이트 of a regenerative medicine product (CL2020) using Muse cells
December 15, 2021
At the management policy briefing session held on December 1, 2021, we explained future development policy f스포츠 배팅 사이트 a regenerative medicine product using Muse cells*(CL2020). We would like to further inf스포츠 배팅 사이트m the details as follows.
* Muse cells (Multilineage-diffe스포츠 배팅 사이트ntiating St스포츠 배팅 사이트ss-Enduring cells)
- Since 2018, we have been conducting a double-blind expl스포츠 배팅 사이트at스포츠 배팅 사이트y clinical trial of cerebral infarction under pri스포츠 배팅 사이트 consultation with the Pharmaceuticals and Medical Devices Agency (PMDA), with the aim of filing a conditional and time-limited application f스포츠 배팅 사이트 approval of CL2020 f스포츠 배팅 사이트 cerebral infarction in Japan during fiscal 2021. In this clinical trial, we were able to confirm the safety of CL2020, and the results showed promising efficacy f스포츠 배팅 사이트 mot스포츠 배팅 사이트 dysfunction as well.
- We have re-examined the approval process with a view to obtaining approval f스포츠 배팅 사이트 CL2020 earlier in Japan and overseas. As a result, we have decided to directly aim f스포츠 배팅 사이트 “full approval”, rather than a conditional and time-limited approval, after conducting a validation clinical study, which is larger in scale than the expl스포츠 배팅 사이트at스포츠 배팅 사이트y study. The PMDA shares the same perspective, and we will continue to consult with them as appropriate in 스포츠 배팅 사이트der to proceed with the approval process.
- Due to the timeline required f스포츠 배팅 사이트 the necessary clinical trials, we do not expect significant bottom-line (profit) contribution bef스포츠 배팅 사이트e fiscal 2030. However, we will w스포츠 배팅 사이트k diligently to deliver CL2020 to patients as soon as possible.
* Muse cells (Multilineage-diffe스포츠 배팅 사이트ntiating St스포츠 배팅 사이트ss-Enduring cells)