posed same question, wording looks odd to me.
sort of suggests that data based of previous study could be used, but then suggests another trial.
if i had the money, i would be into legal action, against FDA, patient has run out with trying to keep them happy.
Very few words are said in public for MSB re the actions and decision of the FDA, ... maybe they should quietly get some of their journo friends doing a series of tabloid spreads, FDA fail again for consistancy with foul smelling outcomes.
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-94
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