Agree.
FDA is expected to inspect the Lonza Singapore, Tuas site as part of the Rem-L BLA review for aGvHD.
In the conference call today Dr Itescu informed shareholders that they have just completed last week (in preparation for the expected FDA inspection review) a successful mock pre-approval inspection of GMP manufacturing facility and our processes; and this mock inspection compromised both on site and virtual inspection by independent auditors.
Promising signs.
Ann: Third Quarter Results Presentation, page-14
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