While there is a great chance of B-OM getting OD status, I had wondered about oral mucositis numbers exceeding 250,000 cases a year(not qualifying for OD), and whether or not the reviewers would buy the argument that B-OM could be approved only for ICU and critical care cases, which would qualify as an orphan drug. The reality is that once approved the oral rinse then can be prescribed for all mucositis, which would not make it an orphan drug in clinical practice.
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