By the way, there is nothing to say FDA have not already reviewed the assays, it probably makes sense, if they accepted on march 7, now 15 days later
They must have looked at the response you would think, prior to booking an inspection.
I love how they have not announced the inspection date either.... No further heads up for the shorts.
Windows opens in 10 days
Just sayin'
Shorts beware
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-109
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