In light of the COVID-19 outbreak, the FDA issued a number of new guidance documents. Study arm initiated under clinical collaboration with BeiGene, Ltd. 3. The overall response rate in nine evaluable patients with CLL was 89%. Sig Transduct Target Ther& 5,& 17 (2020). Competition The marketplace for our drug candidates is highly competitive. In this event, the application must be resubmitted with the additional information. Following product approval, drug products are also subject to annual program fees. Orphan products are also exempt from the PREA requirements. Such authorizations will be without prejudice to the outcome of the arbitration. We believe that our relations with our employees are good. The COVID-19 pandemic and the governmental response continues to rapidly evolve. Our counterparties might not fulfill all of their obligations to us. We intend to have our drug candidates marketed outside the United States. Orphan drug designation must be requested before submitting an NDA. In addition, there is a natural transition period when a new third party commences work. We are exposed to the risk of employee fraud or other misconduct.
