I don't think the Type A meeting request and the timing of the Covid-19 ARDS 2nd interim data results is well aligned.
When submitting the request, Mesoblast needs to supply all the info/ data and at the moment, they don't have the Covid-19 ARDS data.
Also, it may be Mesoblast's decision to go for the full approval rather than the conditional approval; and therefore we need to have a friendly dialog with the FDA rather than a threatening or demanding tone in order to obtain the conditional approval via the Accelerated Approval pathway
MSB Trading 2020 - a new dawn, page-8464
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