SanBio (4592) · FactRestated
SB623 Designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. FDA
First written in FY2020-Q3. 2 of 3 entries say "Restated". Latest entry: FY2021-Q1.
3entries
2years
0from disclosures
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FDA RMAT designation for SB623 for chronic-phase traumatic brain injuryA theme 1 companies write about · 0 as a headwind · 1 as a tailwind
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- FY2021-Q1RestatedAnnual report
「In the United States, the product has also received RMAT designation from the U.S. Food and Drug Administration (FDA).」
The FDA’s RMAT designation of SB623 for chronic traumatic brain injury has been reconfirmed. - FY2020RestatedAnnual report
「In the United States, the Company announced that SB623 for chronic traumatic brain injury received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) in September 2019.」
The FDA’s RMAT designation of SB623 for chronic traumatic brain injury has been reconfirmed. - FY2020-Q3First statedAnnual report
「In the United States, the Company announced that SB623 for chronic traumatic brain injury received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) in September 2019.」
It was first disclosed that SB623 for chronic traumatic brain injury received RMAT designation from the FDA in September 2019.