EFFICACY is the key. "Did Alkermes present substantial evidence of the drug’s efficacy? Twenty panel members voted no, with only 3 yes votes, which makes it extremely unlikely that the FDA’s formal decision would be any different. "

https://endpts.com/fda-experts-gun-down-alker...e%20fronts

IPIX can certainly present substantial evidence of the drug's efficacy against oral mucositis.