FDA 在信中引用了长期安全数据的“突出问题”。然而,Nymox 声称,在 3 月份提交申请之前,该机构在其任何一次交流中...查看全文
产业链观察2022-05-24 18:03
药闻▶2022年5月23日,$耐莫斯制药(NYMX)$ 今天报告说,它已于美国东部时间5月20日星期五下午2:48收到FDA关于公司的Fexapotide Triflutate新药申请("NDA")的拒绝提交("RTF")信。
Nymox的立场是,澄清问题仍需在后续会议上解决,并涉及一些重大的不一致之处。...查看全文
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$耐莫斯制药(NYMX)$ EFFECT Notice of Effectiveness Accession Number: 9999999995-21-002045 Act: 33 Size: 1 KB 网页链接
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