Ann: Submits New Information to FDA IND File for SR-aGVHD, page-237

The items as outlined in the CRL need to be addressed prior to a resubmission:

In December 2021, MSB announced the following:


[...]


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02472385-3A584817?access_token=83ff96335c2d45a094df02a206a39ff4

In May 2022, they then announced that in addition to that new data generated (54-patient Phase 3 trial plus the comparison with 27 closely matched children from the Mount Sinai Acute GVHD International Consortium):



That data plus the above is to be submitted to the FDA:


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02527306-3A594692?access_token=83ff96335c2d45a094df02a206a39ff4

SI now stated that this has been done:


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02576759-3A603647?access_token=83ff96335c2d45a094df02a206a39ff4

Why "NEW INFORMATION TO FDA IND FILE" - because that's what deals with CMC and is the backbone of any future trial using this (remestemcel-L) product, i.e. in ARDS:


https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-chemistry-manufacturing-and-control-cmc-information

It is important to note that CBER has not considered "the adequacy of the clinical data
in the context of the related CMC issues" just yet. That will happen once the resubmission is accepted as mentioned above.

Next step: BLA resubmission.