We are focused on negative questions from the ODAC, but consider what they are implying here.
Like in law, when there is a preceding judgement to reference, this carries a lot of weight to ensure they are consistent in their ruling.
Ruxolitinib (Jakafi), is toxic. with serious side effects and unable to be used in patients under 12. They also showed less efficacy.
YET they were still approved as it is an unmet need for a disease with a high mortality rate.
Remestemcel-L has better efficacy and no safety concerns (side effects).
What is being said below is one of the most pertinent statements from the FDA in their documents. To disapprove would not make any sense.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-536
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