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Re: skyticket1 post# 6985

Tuesday, 03/17/2015 3:19:21 AM

Tuesday, March 17, 2015 3:19:21 AM

Post# of 8299
Tenax therapeutics is collaborating with Imperial College London on the LeoPARDS Trial

Tenax Therapeutics has provided supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis) awarded by the Efficacy and Mechanism Evaluation (EME) Programme and funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. Septic shock represents an area of very high unmet medical need, as the condition is associated with high mortality, morbidity and critical care costs. Given the limited treatment options that exist and the prior research data regarding the potential benefits of levosimendan in septic shock patients, the EME Programme awarded funding of the LeoPARDS trial, which will be led by Imperial College London.

Funding a study without receiving any benefit ? Don't think so.
Funding a study without having discussed with FDA if data is submittable in the US? Don't think so either.
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