Ann: Annual Report to Shareholders, page-75

My sentiments exactly. A few really insightful investors perhaps saw the FDA still ignoring the 9-1 vote on GVHD on potency assay issues and other concerns, but it was a long shot call. I always considered myself sat on 4 not unrelated call options. That all four of them would not come in was most unlikely.

We are still sat on call options, albeit lower value and some might say given the disclosures of the company and past history the delta (probability) of this call option higher than the first GVHD decision:

• At its upcoming scheduled meeting with United States Food & Drug Administration’s (FDA) Office of Tissue and Advanced Therapies (OTAT), Mesoblast will address the appropriateness of potency assays related to remestemcel-L’s proposed anti-inflammatory mechanism of action as well as the outstanding chemistry, manufacturing and controls (CMC) items which could support a resubmission of the current Biologics License Application (BLA) for remestemcel-L in the treatment of SR-aGVHD in children
• The FDA advised Mesoblast that if an additional clinical study in acute respiratory distress syndrome (ARDS) due to COVID-19 showed statistically positive outcomes, it could provide a dataset in conjunction with the recently completed 222 patient clinical study that might be sufficient to support an emergency use authorization (EUA)

If the FDA gives the GVHD BLA application the go ahead, Novartis, a COVID-19 ARDS trial as a preface to an EUA, and expediated CHF, CLBP applications are all suddenly on the cards surely? Or am I being too optimistic? Its anything but a shoo-in, but its a binary outcome if they get the nod....