You keep on harping about this and we have explained at length till we are blue in the face why a RCT is not valid in this case
Read oldtimers post above and if your alzheimers allows …do you remember the ethics committee and Dr Kurtzberg running the trial what they said at the ODAC meeting re the trial would not go ahead if a RCT was required
I am perplexed that you do not understand this nexus
In fact they have promised to run a confirmatory trial as part of the application
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-155
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