MSB 5.83% $1.09 mesoblast limited

Ann: Mesoblast Operational Highlights and Upcoming Milestones, page-50

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    Us noisy investors were asking for an update. This wasn't an update, it was simply a summary of previous announcements. When we said we wanted an update, we meant we wanted more information to the extent they could provide it. Where exactly are they in the FDA appeals process for GVHD? Are they waiting on a decision? On the FDA to actually schedule another meeting? Have they received any updated estimate of a timeline for receiving the Covid ARDs data? Have they formally requested meetings with FDA on accelerated approval for CHF and CLBP, or are they trying to pull everything together that will be included in such a formal request? If so, how long might it be before they are prepared to make those requests? I know things take time, and delays are inevitable, but I don't think it is unreasonable to ask them to provide more accurate timelines, to the extent that they can predict them.
    Last edited by LearningEachDay: 31/03/21
 
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