1. ODAC itself is a public forum, therefore whatever they need to discuss - make it open to the public. If the FDA deemed that the those discussion points needed to be voted on, then make them a voting item - simple!
But, why didn't the FDA make them a voting item?
2. Again. Why didn't they make these issues a voting item. If potency assays are important prior to ODAC, then why have an ODAC meeting until this is resolved? Why accept the BLA and take it this far?
3. Let's say you were on the ODAC panel - what is your input before you cast the vote? Could it in fact be the data???
Do the available data support the efficacy of remestemcel-L in pediatric patients with steroid refractory aGVHD?
MSB Trading 2021 - paradigm shift, page-7833
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