If the FDA was sincere about doing no harm would they not approve on condition that any patient that doesn't respond as predicted gets a second and/or third doses from different batches at no additional cost?
If approved on that basis Mesoblast could rework costs to allow for additional doses when required and get on with saving as many children's lives as possible!
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- Ann: Mesoblast Type A Meeting with FDA
Ann: Mesoblast Type A Meeting with FDA, page-51
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