No, ODAC advisory committee meeting is on 13th, and they will recommend approval or they won't at the end of that meeting (public vote).
The FDA is NOT bound by the ODAC recommendation either way, so it will then be up to the FDA to make a decision, by the schedule no later than 30 September.
Most of us here assume that the ODAC will give Ryoncil the thumbs up given the data, the fact that there is NOTHING for under 12s with AGVHD, etc., and in spite of sh*t posters like Lassman throwing stones.
But it's the FDA approval that we will all be waiting on, regardless of what happens on the 13th.
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