MESOBLAST SP.ADRS 144A/5 WKN: A2AA6U ISIN: US5907171046 Forum: Aktien Thema: Hauptdiskussion

Mesoblast übermittelt neue Informationen an die IND-Datei der FDA als Antwort auf Punkte in der CRL an das Remestemcel-L BLA für SR-aGVHD. Mesoblast hat seit Erhalt der CRL einen aktiven Dialog mit der FDA geführt. https://www.globenewswire.com/news-release/2022/10/02/2526431/0/en/Mesoblast-Submits-New-Information-to-FDA-IND-File-in-Response-to-Items-in-the-CRL-to-the-Remestemcel-L-BLA-for-SR-aGVHD.html

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Upcoming Milestones in Second Half FY2019: • Mesoblast intends to initiate BLA filing for marketing authorization of remestemcel-L following its FDA meeting scheduled for April 2019. • Mesoblast’s partner Tasly is planning to meet with the National Medical Products Administration of China to discuss the regulatory approval pathway for Revascor in China. • Mesoblast intends to meet with the FDA to discuss the pathway for approval of Revascor for the reduction in GI bleeding in patients with LVADs. • All patients in Mesoblast’s Phase 3 trial in MPC-06-ID for chronic lower back pain will complete their 12- month assessment for safety and efficacy.

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