A few quotes from our extremely capable leader SIlviu when interviewed by a biotech research company today ...." The 180 day survival data is an important regulatory and commercial endpoint the FDA wanted to see survival data at 180 days and that data is now in hand there are no clinical hurdles at this point " .. " This data is what the FDA put out as being the critical secondary endpoint as its where most drugs that have tried to treat this disease have fallen over ".. " The FDA specifically wanted this study done to ensure it was a clean study where these children had not been offered or taken any other drugs ,so it's first line therapy " .. " The results are a milestone not only for Mesoblast but for regenerative medicine , we are a long way ahead of any competition " ............After reading parts of this document My thoughts are the FDA are already on the front foot and why wouldn't they with children suffering and dying, also the opioid catastrophe ongoing and political y headlines globally ....Cheers
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- Ann: Day 180 Survival Outcomes In aGvHD Phase 3 Trial
Ann: Day 180 Survival Outcomes In aGvHD Phase 3 Trial, page-66
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