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$1.16 mesoblast limited

Yep that is true. Even if the COVID-19 threat were swept away...

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14/12/21

12:22

Post #: 58280137
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Originally posted by jasonchao: ↑

uh.. This OTAT meeting is see whether SI can demonstrate the appropriate potency assay and CMC items for Remestemcel in aGVHD not assessing the resubmission. FDA said once OTAT gives a tick for potency assay and CMC items then we can resub another BLA for aGVHD. FDA has also said the potency assay must be established before commencing another Phase 3 trial for Covid-19 ARDS. So yes you are correct this OTAT has nothing to do with ARDS but it's the potency assay and CMC items is.

Anyways, you are wrong that Novartis is only interested in Covid-19 ARDS. Don't forget Covid-19 ARDS is a form of ARDS which is a huge market worth billions. EUA under Covid-19 is the easiest way to obtain an approval and from there Mesoblast will conduct all cause ARDS trial. Now why would you gave up billions of dollar in potential revenue? Perhaps we couldn't address the potency assay? Who knows but all eyes are on OTAT meeting outcome. I just don't like the fact Novartis terminated the deal after OTAT meeting.

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Yep that is true. Even if the COVID-19 threat were swept away tomorrow the threat of ARDS from seasonal flu would still remain.

MSB Price at posting: $1.44 Sentiment: Buy Disclosure: Not Held
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