"Recall that the narsoplimab rolling BLA was submitted at the request of FDA, with the understanding that data from the 28 patients treated was sufficient as a pivotal study. I came across a quote from the BofA report, source unverified, as follows: The stock currently trades at $15, and its 52-week high is $24. We do not know the nature of these questions. In May, the FDA extended the PDUFA date to October 17 to review additional material the company had presented in response to questions asked by the FDA. In January, the FDA accepted the company’s BLA and set a PDUFA date of July 17, 2021. The rolling BLA was finally completed in November 2020, a month after producing final efficacy and safety data from the pivotal trial.
Omer stocktwits trial#
In August, OMER jumped 50% after reporting positive data from a trial of narsoplimab in Covid-19 patients with ARDS. Then, in September 2019, the company started a rolling BLA application with the FDA under a priority review. A few months down the line, the FDA approved a response-based primary endpoint.
At that time, it was running a phase 3 trial in HSCT-TMA for OMS721/narsoplimab, and was in ongoing discussions with the FDA about whether it could abandon historical controls or comparative data and simply look at response-based primary endpoints for its trial. I left off Omeros ( NASDAQ: OMER) in February 2019. Hiroshi Watanabe/DigitalVision via Getty Images
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