We refer to this trial as the ACCURACY trial. We plan to report additional data from this trial in 2021. There are currently no FDA-approved therapies for patients with desmoid tumors. Different forms of cancer are associated with different types of Notch mutations. We believe that we possess the largest database of Notch-activating mutations. & & &# 1) Crenigacestat is being developed by Celgene Corporation, recently acquired by BMS. ACC can also arise in other sites outside the head and neck. As of July& 30, 2020, 40 subjects were evaluable for a response using RECIST 1.1. c) Subject #15 had an unconfirmed PR at week 8. On trial, a confirmed PR was observed in this subject’s liver at week 8. However, responses to chemotherapy are not durable and relapse is often rapid. Approximately 65% of all T-ALL patients have Notch-activating mutations. The design of this study, including dose groupings, is depicted below. & The following table represents the most commonly reported TRAEs. & Treatment was discontinued in 15 subjects due to TRAEs. Meetings at other times may be requested. In this event, the NDA must be resubmitted with the additional information. Such off-label uses are common across medical specialties. These changes may lead to additional costs and increase our overall risk exposure. The address of the SEC’s website is www.sec.gov. We were established and began operations in November 2017. The COVID-19 pandemic continues to rapidly evolve. There can be no assurances that we will be able to obtain such designations. However, the FDA has broad discretion whether or not to grant such designations. In addition, there is a natural transition period when a new CRO commences work. Environmental, health and safety laws and regulations are becoming more stringent. These licenses may not be available on reasonable terms or at all. Certain matters of procedure will also be governed by Israeli law. In Syria, a country bordering Israel, a civil war is taking place.
