Good questions.
My view, it will be very difficult using current data. But, if they have success in the Covid-ARDS trial, both issues (stock & consistency) will be addressed. Stock will be consumed and MSB will have more data to support their measurements for batch consistency and in turn the measurements link to efficacy. If efficacy is shown for ARDS, the FDA will work with them post approval of Ryoncil on batch consistency measurements IMO. We should know by year end, and who can't wait for 2020 to end!!
cheers
Ann: Update on BLA for Graft Versus Host Disease, page-349
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