Thought I might just repeat something I mentioned on the trading thread. The FDA announcement to approve (or not) Ryoncil is not a simple yes or no, it must include a well defined label (agreed with the company) with indications, side effects etc, effectively a legal document. But this approval process with Mesoblast is further complicated in that Ryoncil is involved in other clinical trials, in particular the Covid ARDS trial. The problem is that if Ryoncil is approved for GVHD then it can be used off label by physicians -- that presents an ethical problem for the Covid ARDS trial, can you justify giving a placebo when Ryoncil is available off label. This stuff will have to be sorted before Monday.
IMO this announcement is going be a little more interesting than many on HC have appreciated.
Ann: Trading Halt, page-430
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