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Monday, July 08, 2019 9:08:14 PM
Stemline continues to build out a European commercial infrastructure in advance of potential approval by the EMA. A scientific advisory group meeting is planned for September, and the ELZONRIS marketing authorization application (MAA) review will proceed on a standard timeline. Co expects an opinion by the Committee for Medicinal Products for Human Use later this year. If successful, Stemline is targeting a commercial launch in Europe in 1Q20.
In an ongoing market expansion effort, corporate and investigator-sponsored clinical trials with ELZONRIS in additional indications are ongoing in myelofibrosis (MF) and acute myeloid leukemia (AML) and others are planned to roll out later this year and next.
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