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Msg  1978 of 2068  at  1/20/2021 4:51:26 PM  by

billmax


 In response to msg 1977 by  billmax
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Re: Press Release I don't like it

• In December 2020, we dosed our first subject in a Phase 2 clinical trial evaluating DNA medicine INO-4800, our COVID-19 vaccine candidate, as part of our Phase 2/3 clinical trial, called INNOVATE. The Phase 2 segment of the trial will enroll approximately 400 participants who are 18 years or older. In addition, in collaboration with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine), we dosed the first subject in our Phase 2 clinical trial in China. The Phase 2 clinical trial being conducted in China is independent of the INNOVATE Phase 2/3 clinical trial of INO-4800 being advanced in the United States and will enroll approximately 640 participants who are 18 years or older. Advaccine is conducting and funding the Phase 2 trial in China. Our planned clinical development of INO-4800 is currently on partial clinical hold and we may not commence our planned Phase 3 clinical trial of INO-4800 until we satisfactorily resolve the Food and Drug Administration’s, or the FDA’s, questions relating to our CELLECTRA 2000 delivery device. See “Risk Factors—Our planned clinical development of our potential COVID-19 vaccine has been placed on partial clinical hold by the FDA, which may cause delays in the commencement of our planned Phase 3 clinical trial or completion of clinical testing, both of which could result in increased costs to us and delay or limit our ability to proceed to commercialization and generate revenues.”


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