1차 출처 기록
중대신청 접수
디스크 메디슨: bitopertin NDA, CNPV 파일럿 제도 하에 11월 28일 접수
FDA accepted the bitopertin NDA on November 28. The application was selected for the Commissioner’s National Priority Voucher pilot, which shortens the expected review period to 1-2 months and keeps the anticipated action date by the end of January 2026.
핵심 사실
- 제출
- 2025년 12월 8일 PM 01:40
- 이벤트
- 신청 접수
- 방향
- 긍정적
- 출처
- SEC 8-K
- 신뢰도
- 출처 확인
출처 발췌
EX-99.1 2 iron-ex99_1.htm EX-99.1 2025 ASH Management Call December 7, 2025 Confidential Exhibit 99.1 Disclaimer and FLS This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to: (i) the registrational pathway for bitopertin, including the potential for accelerated approval, benefits of the Commissioner’s National Priority Voucher (CNPV) pilot program, and the anticipated review period and action date; (ii) the potential commercial launch of bitopertin, including commercial readiness activities and the timeline for availability of drug supply; (iii) the timing, progress and results of preclinical studies and