I would have thought any FDA feedback from a meeting about CHF would have come via a seperate ASX announcement like the last one on 19/7 ? No one knows exactly when the latest FDA meeting on CHF was held or if it has even taken place yet, much less what the timeframe for feedback in writing from the FDA is through the RMAT designation ? 30 days … 60 days ?
We were only advised this on the 19th July 2022 in a stand alone announcement about treatment of HFrEF patients with rexlemestrocel-L and the meeting hadn’t taken place then according to this paragraph below from that announcement ? I think you will find this will just be the annual run of the mill update in compliance with SEC provisions
Mesoblast now intends to meet with FDA under the RMAT framework to discuss the totality of the data, the evidence of a common MOA across the broad HFrEF spectrum, and how the outcomes from each trial may support the regulatory approval pathway for rexlemestrocel-L.
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- Ann: Mesoblast 2022 Full Year Financial Results Webcast
Ann: Mesoblast 2022 Full Year Financial Results Webcast, page-9
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