MSB met with FDA on 17 Nov to discuss the use of rem-L to treat GVHD, considering FDA did not approve in Sept. FDA has 30 calendar days from this 17 Nov mtg to respond with their revised outcome, or confirm their original ruling stands.
MSB said they will dispute FDAs decision if they don't approve, which they surmised was likely.
Perhaps they have received notification of an approved decision from FDA? Or a decision regardless.
Ann: Trading halt, page-434
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