Hi @Martin37,
that’s undoubtedly the situation now IMO, especially as regards the Lonza Tuas international facility inspection. Given MSB’s confirmation that new assay(s) are involved, an inspection - but logistically might be broken into ‘general’ and ‘release assay specific’ - would probably need to be post-settlement with OTAT of the content of the additional assay(s).
CEO Itescu advised the market some time ago that this inspection sits on the critical path to approval.
As I recall (without checking) he expressed the dependency as ‘determining’ the timing.
BLA resubmission for children with SR-aGVHD, page-4
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