Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-947

re @JSBStrikesBack post 67884267 - a disagreement with the argument is offered

The above has occurred with FDA consultation because, the FDA have approved and Accepted Mesoblast's BLA Resubmission for Remestemcel-L for aGVHD else they would have not approved the resubmission or booked the Lonza inspection in Singapore.

In my opinion this argument has two flawed premises.

1) So long as a BLA submission appears to address each of the points on a complete response letter - it is taken in for full review.

Full review takes time because that is where the proper scientific and statistical analysis is done. You can't do science or statistical analysis without the data. You can't start - there is no point in starting until the client/applicant has given you all they think they can give you to make their argument or you'd have to start over when they added some detail.

2) The very existence of deadlines and KPIs against reviewing times for BLA resubmissions means that the FDA has to forward plan to meet their 6 month deadlines. Booking an inspection ahead of time is necessary to be able to complete all aspects of a project on time. If a project has several things on its critical path and a successful inspection is one - of course you book the inspection - you can always cancel if if it turns out the proposal fails on one of the other steps and the inspection won't be necessary - but to be open minded to the other aspects - like potency assays etc NOT failing - you responsibly need to have a contingent plan for that - you responsibly need to be ready to do an inspection and to meet you KPI of 6 months - else you may not meet it.

Conclusion : It simply doesn't logically follow that mere acceptance of the BLA resubmission into full review and/or booking of an inspection constitute success - they merely indicate the absence of completely obvious failure. The details that matter - the review of the potency assays and the outcome of the inspection are still the weighty details.