SanBio (4592) · InitiativeReframed
U.S. Early Approval Strategy for SB623 Using RMAT
First written in FY2021-Q1. 1 of 2 entries say "Reframed", first in FY2021. Latest entry: FY2021.
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Early approval strategy leveraging FDA RMAT designation for SB623 in the United StatesA theme 1 companies write about · 0 as a headwind · 1 as a tailwind
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- FY2021ReframedAnnual report
「The Company Group will actively capitalize on these changes in the regenerative medicine industry and pursue early marketing approval and launch of its proprietary regenerative medicines.」
Rather than positioning this as a strategy that directly leverages SB623's U.S. RMAT designation, the wording has been broadened to a general expression that aims for the early approval and launch of regenerative medicines by actively leveraging institutional changes in the regenerative medicine industry. - FY2021-Q1First statedAnnual report
「As RMAT is an FDA program designed to promote the practical application of regenerative medicine, the Company Group will enhance its business strategy to facilitate early approval of SB623 in the United States.」
The Company’s policy of enhancing its business strategy toward early approval of SB623 in the United States by using the FDA’s RMAT designation as a regulatory pathway is stated for the first time.