To me the FDA decision to issue the CRL isn't about remestemcell L application for GVHD approval, more likely it is about the use of the therapy off label with out at least some CQA that are measured before release.
That is an interesting idea that I have seen only you put forward so far.
It seems to be implicit to your argument that once the FDA grants a biologic licence application for a product on any grounds, then physicians in the United States automatically also get the discretion (which they didn't have prior to the product having a licence for anything in the US) to then use their own authority to use that product off label on other grounds - so remestemcel-L for other patient ages in GvHD (like adults) and for other indications (like Crohns, like ARDS) in the United States at their own discretion.
Is that your assumption? Do you believe that it is the case that once a licence is granted for even one thing - that the individual physicians of individual patients then get the discretion to use that product off label for other things? Even potentially wildly different things - like chronic heart disease in adults off-label if the patient and the patients physician agree?
CYP Price at posting:
39.0¢ Sentiment: Hold Disclosure: Held
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