Great new, ASX madness. Why would anyone choose to dump after such a announcement? They could have sold yesterday if they were satisfied with their gains.
Next news from the FDA would be around the 23 of this month. Rejection, very unlikely as this is the third BLA , except with either 2 month or 6 month review process. If we were to receive a 2 month review, get set early as in some cases approval can be made in 6 weeks , that would be around the later half of August. By the latest the 10 of September. 6 months would in my view be better as MSB would have a bit more time on hand to address any minor matters that the FDA need rectified. This would not necessarily mean a January decision, any thing that the FDA considers would take more than 2 months would receive a 6 month review.
Further market sensitive announcement due 1 week from news from FDA . Should be a good month.
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Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-114
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