Omeros responding to 'correct some of the inaccuracies' in Statnews.com story
Omeros Corporation stated that it continues to pursue legal action to hold responsible those behind a series of defamatory reports about the company posted online under the pseudonym "Art Doyle," an entity or group that self-identifies as having a short position in Omeros' stock. "Because of its ongoing legal action, including a number of steps aimed at unmasking the identity of the individual(s) responsible, Omeros elected not to respond to queries from a writer for statnews.com who evidently had early access to and commented through Twitter on the initial "Art Doyle" false report before it was broadly made public. While, for the reason stated above, Omeros will not engage in a running dialogue with this writer, the company will respond this one time to correct some of the inaccuracies in yesterday's statnews.com story," the company said. Additionally, Omeros said: "As of June 30, 2017, 54 patients had been enrolled in OMS721 Phase 2 clinical trials. Since then, the enrollment number has continued to increase. Presentations of OMS721 clinical data at international scientific meetings span February 2017 through June 2017. These presentations are directed to respective groups of patients and are not intended to reflect total patient counts. In addition, like most biopharmaceutical companies, Omeros does not routinely release all clinical data as they are generated. As noted in the company's press release dated August 4, 2017, more than 150 subjects had been dosed with OMS721, and that number continues to increase. On March 16, 2017, Omeros publicly announced that enrollment had opened for its Phase 3 clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome, or aHUS. In connection with this study and consistent with regulations governing clinicaltrials.gov postings, a clinicaltrials.gov filing was made by the company on April 17, 2017. This date, as recorded by the website administrators at the National Institutes of Health, is found on the clinicaltrials.gov summary for this Phase 3 trial. The estimated completion date of the aHUS Phase 3 clinical trial for approximately 80 patients is listed as 2020 on clinicaltrials.gov. The posting on clinicaltrials.gov also clearly states that an interim analysis will be conducted following treatment of approximately 40 patients for potential submission for regulatory approval. This is consistent with Omeros' publicly available statements that, based on discussions with both FDA and the European Medicines Agency, the company received guidance from those regulatory bodies that 40 patients may be sufficient for accelerated approval in the U.S. and for full approval in Europe...Omeros, for competitive reasons and consistent with common practice in the industry, has not released any PK/PD data."