Not sure why you hold stock if expecting an inevitable CRL?
Me, I will stick with the company advising of a successful mock
inspection , Lonza Houston 5 FDA approvals, unmet need and
4 year survival results.
Oh , and that the FDA overruled their ODAC committee re
efficacy
Bit of a rant - but mock inspection on a modern Lonza plant is a big tick .
Reg
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-165
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