The share price of Northfield plummeted more than 50% following Northfield's preliminary report of top-line data from its Phase III trial assessing the safety and efficacy of PolyHeme(R), its human hemoglobin based oxygen-carrying red blood cell substitute.
Northfield and its contract research organization agree there were some errors in the data - some of the deaths were study patients not per protocol - and will unlock the database, correct the errors, verify the database and then re-lock the database.
In short, the data as reported to date reveals that more deaths occurred when PolyHeme was administered than in the control group - thus PolyHeme is not a superior treatment and the number of death was large enough that PolyHeme also failed the non inferior barrier as well.
Whether the corrected and verified database will reverse the preliminary results enough (or at all) to warrant FDA approval PolyHeme remains an unknown. Northfield remains publicly optimistic and expects to release additional safety date within 4-6 weeks.
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