We refer to myeloma that is refractory to these five agents as penta-refractory. 8226; Dosed first patient in June 2020 in the XPORT-GBM-029 Study. A membrane, called the nuclear membrane, separates the nucleus from the cytoplasm. Key clinical trials of selinexor are summarized in the charts below. Serious adverse reactions occurred in 52% of patients who received XVd. Treatment discontinuation rate due to adverse reactions was 27%. 2 Based on interim unaudited data. The median PFS was 23.7 months for all patients. In this population, XPOVIO demonstrated an ORR of 29%, including a CR rate of 13%. In June 2020, we dosed the first patient in this study. Any patents issued in foreign jurisdictions will likewise expire in 2040. There are four issued U.S. patents that cover verdinexor. In many cases, these drugs are administered in combination to enhance efficacy. The FDA may request additional information rather than accept an NDA for filing. The Regulation was published on June 16, 2014 but has not yet become effective. The website indicated that the audit was expected to commence in December 2020. Coverage policies and third-party reimbursement rates may change at any time. As of February 16, 2021, we had 432 employees. Mr. Frenkel received a BPharm from Hebrew University. These confirmatory trials must be completed with due diligence. Similar restrictions apply to the approval of our products in the EU. We may not be able to obtain orphan drug exclusivity for our product candidates. The applicable period is seven years in the U.S. and ten years in Europe. Thereafter, the U.S. Supreme Court agreed to hear this case. Infringement of these laws could result in substantial fines and imprisonment. Our net loss was $196.3 million for the year ended December 31, 2020. We will need additional funding to achieve our business objectives. We may also incur additional indebtedness to meet future financing needs. In these cases, our business could be materially harmed. All contain numerous tax provisions.