We have one approved drug, QINLOCK, which was developed through our proprietary platform. The study is being conducted at 122 investigational sites in 22 countries. We also announced plans to file a U.K. MAA for QINLOCK in fourth-line GIST. We successfully completed enrollment of 453 patients in INTRIGUE. GIST can occur at any age, but is more common in individuals aged over 50 years. However, regorafenib does not inhibit all KIT mutations in exon 17 or 18. Cambridge, MA: Blueprint Medicines Corp; 2020; (10) Lopes LF, Bacchi CE. Vimseltinib was generally well-tolerated in patients with TGCT not amenable to surgery. No SAEs related to vimseltinib were reported in the TGCT patients. The following figure depicts the results of these assays. Median treatment duration for the mITT population was 4.2 months. Rebastinib in combination with carboplatin was generally well-tolerated. Drugs are also subject to other federal, state, and local statutes and regulations. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials. In this event, the application must be resubmitted with the additional information. FDA review of an initial PMA may require several years to complete. This has led to significant variations in the Member State regimes. This is currently expected to occur in December 2021. There is no certainty that an adequacy decision will be granted. Unlike Medicare Parts A and B, Part D coverage is not standardized. This final rule codified the CMS\'s policy change that was effective January 1, 2019. The market implications of the final rule and guidance are unknown at this time. Moreover, data subjects can claim damages resulting from infringement of the GPDR. ITEM 1A. RISK FACTORSOur business is subject to numerous material and other risks. We may face other limitations or issues related to the price of QINLOCK. As a result, increasingly high barriers are being erected to the entry of new products. In March 2010, the ACA was enacted into law. We generally contract with third parties for the disposal of these materials and wastes. We currently have no products that are approved for sale with the exception of QINLOCK. Three of our drug candidates are only in Phase 1 or Phase 1/2 studies. It is unknown how long these disruptions could continue, were they to occur. We commenced operations in 2003. Adequate additional funds may not be available to us on acceptable terms, or at all. As a general matter, our manufacturers represent our sole source of supply.
