A Retrospective View of the Accelerated FDA Approval Process for Mesoblast Stakeholders
Silviu Itescu, managing director of an Australian biotechnology company, Mesoblast, and its CFO, Josh Munter were sued in a class action complaint in October 2020. Investors claimed that they suffered severe losses due to Mesoblast making misleading statements and not disclosing important information about the company’s drug candidate, Ryoncil. Mesoblast management took the approach to settling the lawsuit and simultaneously asked the FDA for accelerated approval of Ryoncil without conducting new clinical trials. In retrospect, the managing director wondered if the decision to pay fines and ask the FDA to accelerate the Ryoncil approval process was a more effective management approach than conducting the new clinical trial suggested by FDA. Students are asked to take a stakeholder’s perspective in their assessment of the effectiveness of past management decisions in the areas of ethics, leadership, and strategy.