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Rockwell Medical, Inc. Message Board

  • a_rajalonghorn a_rajalonghorn Jun 1, 2013 2:42 PM Flag

    RMTI Bull Analysis (part 5)

    "The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). Baseline ESA dose was similar between SFP (9483 U/wk) and placebo (9205 U/wk). In the modified ITT population, at the end of the study, ESA dose in the SFP arm was 9871 U/wk and placebo was 12628 U/wk. After adjusting for differences in baseline hemoglobin, the SFP arm required 35% less prescribed ESA compared to placebo. The difference between the two groups was statistically significant (p=0.045). The ESA sparing effect from SFP was observed without any increase in serum ferritin or pre-dialysis transferrin saturation. The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 35% while maintaining iron balance and maximizing iron delivery."

    Considering that the market for ESA's in the U.S is approx $2 Billion and AMGEN recently paid $24.9 million dollars for settling allegations for doing pharmacy kickbacks for using their ESA drug over competitors; this appears to be a lucrative market. A 35% reduction in the usage of ESA's is quite an achievement, IF THE RESULTS ARE REPRODUCED IN PHASE III. Now granted, the company has a jaded history be of being less than forthright with investors, its still a gamble. However; looking through the FDA website and their clinical data, it seems to be a sure bet that they will met their primary endpoint.

    Sentiment: Strong Buy

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