Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-266

"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 ?"

And you keep inferring that they wouldn't carry out steps in the approval process without having completed a previous step ie. already made a decision to grant approval. But then why convene an ODAC committe meeting last time if they had already decided to issue a CRL? Clearly the FDA approval process doesn't quite follow the same workflow that you think it does. Why would there still be a back and forth communicaton with questions about the application if the FDA were already as satisfied as you claim? Some items are obviously carried out concurrently and the entire evidence compliled by the experts is submitted to those making the decision.