Ryoncil: ODAC/FDA Meeting Discussion, page-1755

Mesoblast scores US regulatory breakthrough
Tom Richardson and Carrie LaFrenz
Aug 14, 2020 – 7.31am
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A US healthcare Oncologic Drugs Advisory Committee (ODAC) meeting has voted eight to two in favour of a Mesoblast drug to treat transplant rejections in children.
The verdict was delivered about 7am AEST after the US Food and Drug Administration's (FDA) Advisory Committee majority voted the available clinical data supplied by Mesoblast support the efficacy of its Ryoncil drug in pediatric patients with acute-Graft Versus Host Disease (aGVHD).
The final decision on whether to approve Mesoblast's Ryoncil drug for marketing is now expected to be made by the FDA before September 30.
The all-day meeting that included representations from Mesoblast's senior management team discussed both the adequacy of the product mechanism's delivery and whether a further clinical trial is needed to support the drug's efficacy.
The company also has an ongoing Phase 3 trial in progress to measure the effectiveness of a stem-cell therapy to treat ventilator-dependent COVID-19 patients. The first read out from an initial 90 patients involved in this trial is due by September.
Mesoblast has suggested it will hold a call with analysts to discuss the FDA committee's verdict about 10.30am on Friday.
The company put its shares into a trading halt late on Thursday on the Australian stock exchange.