Omeros (OMER) on Wednesday sought to defend its experimental drug OMS721 with a press release responding to my story raising key questions about the drug.

But it didn’t actually clear anything up.

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  • Adam,
    Check line 4 from this excerpt from Clinical Trials.gov. Clearly states intravenous loading followed by subcutaneous injections for this registrational PIII trial.

    Experimental: OMS721
    Administration of OMS721
    Biological: OMS721
    Intravenous loading dose followed by daily subcutaneous injections

    Detailed Description:
    This is a Phase 3, multicenter study of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The uncontrolled, open-label study will evaluate the effect of OMS721 in subjects with plasma therapy-resistant aHUS and plasma therapy-responsive aHUS. This study has four periods: Screening, Treatment Induction, Treatment Maintenance, and Follow-up. Approximate enrollment is 80 subjects. An interim analysis will be performed after 40 subjects have completed 26 weeks of treatment for potential registration.

    https://clinicaltrials.gov/ct2/show/study/NCT03205995?term=oms721&rank=2#contacts

  • Show me a statement where Omeros has pitched 721 as blockbuster to replace Soliris? That is a statement you have made. The company itself as indicated that the IgaN P3 will likely be completed before ahus P3 and the stocks run up is mostly linked to IgaN results.

  • As a novice investor, I am very surprised that people like you and “Art Doyle” are allowed to spread false information about a company in order to profit in the possible decrease in value of this company’s stock. The false info provided by “Art Doyle” has already been disproved in court, but I suppose individuals like yourself don’t concern themselves much with facts but are only interested in marking profits whatever the cost might be to honest investors, companies, and to patients who would greatly benefit from new drugs.

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