Yeah the key for cellular therapies coupled with manufacturing and FDA approval (initial + ongoing re: approval mode) is the IP in the array matrix, which Si is clearly reiterating was effectively in place for MSB-GVHD0001, clarification of which has now been accepted by FDA. Should turn the real scientists back on in my ignore list at this critical juncture but...nah, easter Sunday's no time for religious zealots.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-480
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