“which requires a successful FDA inspection of the facility handling the manufacturing of our product, including Lonza’s manufacturing facilities”
I would have thought if the FDA had gone through and inspected Lonza’s manufacturing facility, if they had problems they would be told to rectify them, especially any major problems on inspection would of caused a quick disapproval, instead there has been 6 months worth of product being made for gvhd on approval.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-848
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