The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the rare pediatric disease product application.
The Secretary shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric disease product application.
FDA Fast Track Designation. This is a program the FDA uses to fosters accelerated development and review of drugs that treat conditions with an unmet clinical need. We are targeting a submission by the end of October. RPDD RNS application 8th of Nov. So I would guess so
Investment/fund manager: All managers of lawfully managed investments, operators of collective schemes and investment companies with variable capital can disclose at minimum thresholds (5% and 10%) and not lower 3% with incremental 1% that apply for holdings in UK issuers. Above 10% the 1% incremental thresholds apply.