Mesoblast CC Transcript 31/8, page-27

You cannot exclude it as a possibility, given SI's comments:

"We believe that we can link the product that was made in the Phase 3 trial to the current commercially risk product through additional work using potency data."

"The Type A meeting with the FDA is scheduled to be held in mid-September, and we will be laying out these exact strategies. We proposed providing FDA with additional potency assay data to provide the link between Phase 3 product and the current commercial inventory. We also proposed providing FDA with new clinical trial data in adults, which could also support the pediatric indication."

It would also be understandable for investors to doubt SI's ability to convince the FDA of the linked potency assay evidence being enough for them to grant approval. But if you read the FDA's Peter Marks discussion in Endpoints, that is so relevant to MSB, that other posters kindly posted and this webcast above, that@col69 kindly posted, you could be very forgiven for concluding, failing the convincing of the FDA at the September meeting, MSB likely being granted an accelerated approval, ONCE, a new trial with the Blood and Bone Marrow Clinical Trials Network, is well and truly underway, and it approved with the firm stipulation of that as a confirmatory trial.

I cannot believe people are discussing anything other than this webcast. So much information. Criticisms of SI and co. were understandable. Clarification of the first CRL was poor IMO. This is not. There is excellent and full and detailed disclosure of information on the CRL and according action in here. The cut in salaries for options/shares no insignificant either. Suspect someone at MSB actually reading Hot Copper and the 'insider signaling' in that move the icing on the cake for me.

"When there is blood on the street, even when its your own, that is often the time to buy".