The Lund‑based company has been granted Rare Pediatric Disease Designation, which means that the FDA formally confirms that the drug candidate TCP‑25 targets a serious, rare, and primarily pediatric disease.
This in turn gives the company the possibility, if the drug is approved, to apply for a Priority Review Voucher (PRV). Such a voucher can provide priority FDA review for another project, and it can also be sold — often for a substantial amount.
BREAKING