Replies to post #215018 on Biotech Values

[biomaven0]

>>OMER

>>reimbursement change coming in 2018.

It's so weird that this came as a surprise to the market. I know rkrw mentioned it to me late last year if I recall correctly, and there has been warning language in their filings for a long time.

[biotech jim]

I am in Omeros for OMS-721 and kidney applications including both nephropathies and glomerulopathies.

Having said that, the most important info related to OMS-721 and interactions with the FDA.

From the earnings PR:

Highlights and developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS) and hematopoietic stem cell-associated TMA (HSCT-TMA), and for the treatment of complement-related renal diseases, including IgA nephropathy, include:

1. Omeros met with the FDA in follow-up to the FDA’s granting breakthrough designation for OMS721 in IgA nephropathy to discuss Phase 3 trial design. The Agency’s meeting minutes make clear that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint. Depending on the size of the effect on proteinuria, either full approval or accelerated approval is possible. If full approval is granted based on reduction in proteinuria, estimated glomerular filtration rate (eGFR) will be followed as part of the safety assessment. Any effect of OMS721 on eGFR is likely to result in additional label claims for the product. If, based on the effect on proteinuria, accelerated rather than full approval is granted, marketing of OMS721 would be allowed during which time confirmatory data on long-term effects of OMS721 on eGFR would be collected. These eGFR data, if satisfactory, would then form the basis for full approval.

http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-newsArticle_Print&ID=2316004