"In order for MSB to unequivocally satisfy the FDA's concerns, they would need to dose patients with remestemcel-l that they consider an inferior quality vs a high quality product..."Yes, that would be unethical and completely unfeasible. Remember, as explained in the AM session, identifying CQA's is a very slow and deliberate process requiring very large datasets. To generate in-vivo data to identify new CQA's will literally require thousands of patients to find any small treatment effects between unintended differences in attributes generated by the 'imperfect' manufacting process, rather than a deliberate variation in MSC's (sick kids are not guinea pigs).
This is the only way generate the gold standard data the FDA has put forward as the benchmark. We are talking about many years delay for a treatment which was voted to be effective now using the existing manufacturing processes by the expert panel.
The CQA issue can only be truly addressed by approving Rem-L. No doubt, MSB have made that case with the FDA.
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- Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-744
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