With my optimist hat on - they wanted the data to consider phase 4 as the next trial
With my pessimist hat on - they wanted the data to agree with MSB on exactly who would be treated and weather they would possibly grant an approval based on a selected group for the next phase 3.We all heard the arguments put forward in the ODAC when they said why doesn't this work on adults, why only children, why not grandparents etc.... This ischemic sub group or inflamed subgroup probably need the FDA to agree on the " why" it works on that group, and if that group is a group, before considering if they would approve or initiating another trial.
Cell Therapy News/Articles, page-13478
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