Yes- BUT , as it was an unmet need- they could approve , treat and sort out the rest later.
I concur fully re manufacturing.
So, what if the FDA is still not satisfied- do they refuse to treat our most vulnerable again?
I would not want to be making that decision with 4 years of data demonstrating superior efficacy.
Reg
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-19
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