Kompaniya avvalroq 20-yil 2021-oktabrda FDA tomonidan o‘tkazilgan tadqiqotga qo‘yilgan klinik holatni e’lon qildi. Kompaniya 18-yil 2021-noyabrda bu boradagi yangilanishni taqdim etdi va 9-yil 2021-dekabrda yangi tadqiqot dori (IND) ilovasi uchun FDAga o‘zgartirish kiritdi. Shu haftada olingan xabarnoma orqali FDA klinik saqlashni olib tashladi va maslahat berdi. O'qishni davom ettirishga harakat qiling.
Rivojlanishni sharhlar ekan, rais va bosh direktor Greg MakKi shunday dedi: “Biz Florida universiteti bilan hamkorligimiz orqali ortiqcha ovqatlanish buzilishi bo'yicha 2a-bosqich klinik sinovini olg'a siljitishdan xursandmiz. FDA bilan suhbatimiz samarali bo'ldi va ushbu tadqiqot dizaynini sezilarli darajada yaxshiladi. Bu 2021 yilda FDAdan boshlash uchun ruxsat olgan ikkinchi klinik tadqiqotdir.
USHBU MAQOLADAN NIMA OLISH KERAK:
- The Company provided an update on the matter on November 18, 2021 and submitted an amendment to the FDA for the Investigational New Drug (IND) application on December 9, 2021.
- Through the notice received this week, the FDA removed the clinical hold and advised Tryp that it can continue with the study.
- Commenting on the development, Chairman and CEO Greg McKee said, “We are excited to move forward with our Phase 2a clinical trial in binge eating disorder through our partnership with the University of Florida.
