Finally - great news...
We can see progress from the FDA side, they are not waiting to review the assays - they are going full steam ahead with a manufacturing site inspection. This is a step up from the original BLA and serve as a confidence booster for me in terms of one step closer to Ryoncil approval.
As we LTSHs have been suspecting, the market will catch up and the SP will appreciate accordingly
GL MSB'ers - onwards and upwards
BTW - I'm glad that we have something tangible to discuss, rather than the trolling and the responses to read!
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-21
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