Ann: Change of Director's Interest Notice - Silviu Itescu, page-113

The refusal for approval was based on documented deficiencies in the trial protocol and methodology (derived controls and potency assay) for the aGVHD trial. The FDA bent over backwards to allow MSB to try and present new evidence and they failed on two BLA submissions. MSB has repeatedly challenged the FDA decisions and refused to take carry out the FDA's recommended pathway to approval. The totality of the data doesn't support efficacy at all (repeated failed trials). Sorry, MSB don't have a leg to stand on. See Southoz's criticisms. But if you are relying on Mesoblast to threaten the FDA with litigation as a pathway to approval, then that's even more desperate than SI's cap raise and proposals.