RE:RE:RE:RE:Recent chinese articleSPCEO1 wrote: Presumbably, the 10/3 date for approval comes from someone inside TaiMed. I suppose it is possible the FDA would tell them such a date and I suppose it is also possible that someone at TaiMed would make a mistake and tell someone outside the company. While possible, however, I don't think it is likely. Still the timeframe makes sense. So, whether the information was accurately sourced or not, it could well turn out to e basically correct.
Approvals are almost always given on Fridays and 10/3 is a Tuesday. So, that also makes me think it may not be official info but the musings of someone not associated with TaiMed or the FDA.
It's official announcement from Taimed's website.
https://www.taimedbiologics.com/cht/news/info/62 The translation by Baidu is as below:
The company has received U.S. Food and Drug Administration (FDA) Notice, the company formally accepted the proposed TMB-355 biologics drug registration (BLA) application, and priority review (Priority Review) qualification review process is shortened to six months. According to the current regulations, if the BLA application is accepted by the FDA in all the files into the FDA after 60 days as the official date of application. As a result of our delivery in May 3rd of 106, the official application date was set as July 3rd. The review deadline for TMB-355 Prescription Drug User Fee Act (PDUFA) date is 2018 in January 3rd. FDA and notify that if there is no major deficiency, the company will receive the drug label and the relevant regulations and requirements for TMB-355 listing in 2017 October 3rd. In addition, FDA currently considers that TMB-355 is not required to consult the Advisory Committee before approval of the drug certificate.
TMB-355 has previously been approved by the US FDA for "rapid review" and is eligible for use in multiple drug resistant patients, "orphan drugs" and "breakthrough therapy". The "qualified review" will speed up the listing of future drugs.