As far as I can see 114 days have already passed , the Novartis deal was signed on the 19th November , the deal seems only subject to the expiration or termination of the waiting period under the heart scott-Rodino Antitrust Improvement Act and other certain conditions ?? I do not think Novartis is in control of this timing or could or want to withdraw ? am I missing something ? who knows ?
Melbourne, Australia; November 20, and New York, USA; November 19, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), today announced that it has entered into an exclusive worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell (MSC) product remestemcel-L, with an initial focus on the development of the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.
The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.
ARDS is an area of significant unmet need, with a high mortality rate despite current standard of care, which includes prolonged ICU treatment and mechanical ventilation. As the potential first ARDS therapy, remestemcel-L will be evaluated to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase 3 study, where even with maximal existing therapies, mortality is estimated to be even higher. Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current study.
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