Mesoblast also stated in their 23 November presentation that there was the 'potential' for first product launch in H1 CY2023 - doesn't mean it will happen but perhaps they anticipate a shorter PDUFA date than 6 months ? Who knows .... the fact is we will know when (IF) the FDA accept the BLA resubmission and issue the new PDUFA date
"Mesoblast is working towards a potential US approval for remestemcel-L and first product launch in H1 CY2023"
Happy New Year MSB'ers and GLTAH
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