In hypomethylating agent, or HMA, and venetoclax naïve patients, the ORR was 43%. The primary endpoint of the trial will be the CR rate. The maximum tolerated dose for continuous daily dosing was achieved at 3 mg. 8226; The median time to initial response was 1.2 months. &# Ovarian cancer is the fifth most common cause of cancer death in women. See "—License and Collaboration Agreements–Global Blood Therapeutics" below. One of our issued patents, U.S. Patent No. A third patent, U.S. Patent No. We believe these five U.S. patents are eligible for listing in the FDA's "Orange Book." Patent term extensions could result in later expiration dates. In addition, we have an option to co-promote the first product in the United States. There are a variety of available drug therapies marketed for cancer. PMA applications are subject to an application fee. Thereafter, the U.S. Supreme Court agreed to hear this case. The EMA has indicated that the system will go live in December 2021. As of December 31, 2020, we had an accumulated deficit of $377.0 million. We expect our expenses to increase in connection with our planned operations. We refer to the Loan and Security Agreement with Oxford as the Loan Agreement. 42 In the near term, we are dependent on the success of SY-1425, SY-2101 and SY-5609. We have never obtained marketing approval for a product candidate. We depend upon our license with TMRC, and we may not be able to maintain that license. In this case, we could ultimately be forced to cease use of such trademarks. Such a license may not be available on commercially reasonable terms or at all. The approval procedure varies among countries and can involve additional testing. A broad range of legislative measures also have been introduced at the federal level.
