Financial SupportThe study is funded by a grant from the National Institute of Health, offsetting study expenses and providing financial support.
Regulatory DesignationsLaromestrocel has Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, which could expedite its approval process.
Regulatory SupportThe FDA's ongoing commitment to streamlining approvals for rare diseases, particularly rare pediatric diseases, is expected to support the company's filing on a positive note.