Spot on, don't forget JB's great knowledge of the potency assay that he claims to have is a bit short on facts like a chart that likely has the data of around 40 patients on it yet he says its more like 11 despite admitting incorrectly filtering 25 patients ( according to him only minor)
Perhaps JB should ask himself a different question.
With the potency assay he believes MSB has would it be appropriate for MSB not to use it? It obviously has to be included as it demonstrates a critical attribute of our cells. Has he understood the FDAs requirements for a final potency assay? From memory it goes along the lines of " give us a attribute of the product that has been shown to be critical for the outcome of the patient "
Has MSB achieved this requirement? Yes as there is no way the FDA would allow this assay not to be included in a final potency assay.
JB has pointed to the possibility that other attributes could be critical to the patients outcome. I have no doubt that he would be correct. I also have no doubt that MSB has adressed this by setting a product standard including many cell attributes with parameters set on past lots passing the potency assay and showing out standing results. These attributes don't need to be linked to critical outcomes just that they know that the cells work between certain levels of that attribute.
6 days before FDA should respond to our BLA.
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