MSB 2022 - The road to commercialisation, page-4

@stockrock have you seen this? https://www.fda.gov/media/84417/download
This explains the BLA resubmission - I'll have another read of it, but I think you may be able to digest this better than me.

I'm assuming the Ryoncil resubmission as a Class 2 Resubmissions, due to the following qualifications:
3. Any data other than minor assay validation.
4. Any resubmission with large amounts of data such as data to supportprocess performance qualification

In terms of timeframe, it looks like the standard 6 month PDUFA - but, it should be shorter without the need for ODAC.
CBER will review and act on Class 1 and Class 2 Resubmissions for PDUFAapplications or efficacy supplements within the timeframes specified in thecurrent PDUFA goal letter as follows:
1. Class 1 within 2 months of the receipt date.
2. Class 2 within 6 months of the receipt date

Anyway, after many false starts we may be on our way to commercialisation - if we get the BLA resubmission going soon