Ibalizumab BLA review meeting result https://mops.twse.com.tw/mops/web/t05sr01_1
Company code:4147
Taimed just officially announced: (Baidu translation is as below)
The company held the mid term meeting of the TMB-355 BLA review at FDA on August 18th in the United States (Post-Midcycle
Meeting). FDA provides guidance on the results of the current review and the parts that need to be filled. The meeting went smoothly without targeting drugs
Risk assessment and management of physical security. FDA and inform the BLA review of the late meeting (Late-Cycle Meeting) has been booked
In October 31st, FDA also notified again that there was no need for an expert consultation meeting and that it would be held before October 3rd
Know the details of the company's labeling of TMB-355 drugs.