From the Taiwan side https://www.moneydj.com/KMDJ/News/NewsViewer.aspx?a=a94c8972-82ae-4e70-a2b3-b0a858a3cc90
Zhongyu: Letter from US FDA Extension of TMB-355 Drug Card Examination
Response (0) Popularity ( 471 ) Bookmark (0) 2017/11/14 07:51
Public information station major news announcement
(4147) Zhongyu announced a letter from the U.S. FDA to extend the review of TMB-355 drug certification
1. Facts happening day: 106/11/14
2. Company Name: Zhongyu new drugs
3. And the company (please enter the company or subsidiary): The Company
4. Mutual shareholding ratio: not applicable
5. Causes:
The Company received a notification from the U.S. FDA on November 13 that it will extend the review of the TMB-355 Medicines application due date (PDUFA Date) by three months to April 3, 2018. Zhongyu sent additional information on the production of pharmaceutical products and revised the original version of the delivery on October 25. After an initial reading, the FDA decided it would take more time to complete the review of the supplemental information. The three-month extension is the FDA's standard procedure for extending the review. In the letter, FDA did not ask Zhongyu to provide more information.
6. Response: None
7. Other items that should be stated: long duration of development of new drugs, high investment costs and unsubstantiated success, which may put the investment at risk and investors should exercise prudent prudence in judicious investment.