2023 The Final Countdown, page-26

MSB has now resubmitted the Biological License Application (BLA) to the US FDA for approval of remestemcel-L for the treatment of paediatric steroid refractory acute graft versus host disease (SR-aGvHD). The resubmission comes more than two years after the FDA’s complete response letter (CRL) to the initial BLA. The next steps include notification (from FDA) that the dossier has been accepted for a review followed by an expected PDUFA date in July 2023.The most crucial new data in the BLA relates to potency assays for individual product batches and the long term (4 year) survival data from the company’s earlier phase 3 trial involving 54 patients with predominantly severe grade C/D disease.We note that prior to the PDUFA data in 2020 the company’s market capitalisation increased to ~ $3.1bn in anticipation of approval. Based on the current shares on issue the implied share price is ~$4.20.

Aloha.