BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-fda-cgt-prior-knowledge-guidance-comment-window-2026@catalyst-calendar.local
DTSTAMP:20260720T200530Z
DTSTART:20260602T130000Z
DTEND:20260602T133000Z
SUMMARY:FDA基因治疗利用既有知识开发指南征求意见窗口
DESCRIPTION:FDA于6月2日发布基因治疗开发中利用既有科学和平台知识的draft guidance，并设90天公开意见期；该政策窗口可能影响细胞与基因治疗公司开发成本、CMC策略和监管可预期性。\\nImpact score: 64\\nExpected: 行业提交意见并评估FDA是否形成更可复制的平台型CGT审评框架，影响开发成本、IND/BLA资料准备和小样本罕见病项目可行性。\\nAffected: XBI(etf\, mixed\, score 58)\; IBB(etf\, mixed\, score 52)\; CRSP(theme\, mixed\, score 55)\; NTLA(theme\, mixed\, score 55)\; BEAM(theme\, mixed\, score 52)\\nSources: FDA press announcement: https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-help-accelerate-cell-and-gene-therapies-patients\\nFDA Cellular and Gene Therapy Guidances: https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-cgt-prior-knowledge-guidance-comment-window-2026
CATEGORIES:policy\,MACRO\,FDA\,cell therapy\,gene therapy\,guidance\,CMC
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: FDA基因治疗利用既有知识开发指南征求意见窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: FDA基因治疗利用既有知识开发指南征求意见窗口
END:VALARM
END:VEVENT
END:VCALENDAR