UnknownUnicorn19246015

$SRNE entry PT 8.75-9 PT 17 and higher

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Sorrento receives MHRA authorization to conduct Phase 2 COVI-DROPS trial Sorrento Therapeutics announced that the Medicines and Healthcare products Regulatory Agency, the United Kingdom's regulatory agency, has cleared Sorrento's COVI-DROPS product candidate for a Phase 2 efficacy trial. The application was submitted as a rolling application and the MHRA cleared the study in less than a month from Sorrento's first submission to the MHRA. The application was supported by the safety data from a healthy subject study completed in the US, which showed a safety profile comparable to placebo with doses up to 60 mg. In this study, there were no serious adverse effects or dose limiting toxicities and all adverse effects were mild in severity. The maximum tolerated dose was not reached. The Phase 2 efficacy trial is a large double-blind clinical trial enrolling 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms in a 2:2:1 randomization with patients receiving 10mg, 20mg or placebo. This trial will complement the Phase 2 trial currently being started in the US and a separate trial to be started in Mexico.
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