No…
Phase 3 trial in sr-aGvHd in under 12’s …passed primary endpoints.CRL issued about CMC
Phase 3 trial in LVAD …….bleeding in the gut as secondary endpoint accepted by FDA
Phase 3 trial in CLBP …..endpoint in functionality missed but pain accepted in further confirmatory trial due to opiod addiction
Phase 3 trial in CHF …dream failed in hospitilisations but secondary endpoints in diabetecs accepted Now FDA is processing what is the next stage
IE if these 4 trials continue to another trial it is effectively a phase 4 trial
MSB 2022 - The road to commercialisation, page-1427
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