.... you keep saying this without recognising that the FDA must have been at least somewhat satisfied with the data in the BLA resubmission or why send 4 people for 10 days to undertake a 'very thorough' (your words not mine) inspection of the Lonza facility ?
Seems like resources they can't really spare when they were complaining just over a year ago about the huge (wait for it) "inspection backlog" ? .... but do go on about the FDA 'recommendation' to undertake a new trial under these circumstances if it makes you feel better ? My bet is the FDA were happy enough with the "Complete Response" by Mesoblast (hence why they accepted the BLA resubmission) to their original CRL to allocate these limited resources to undertake this inspection in Singapore in this instance - just sayin'
https://www.fiercepharma.com/pharma...ts-manufacturing-site-inspection-backlog-2022
2022 forecast: Can the FDA whittle down its manufacturing site inspection backlog next year?
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-263
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