Dr P is sort of an add-on to the trials, which are
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Posted On: 05/18/2020 10:11:08 AM
Re: Good to go #34369
Dr P is sort of an add-on to the trials, which are clinical trials. Dr P does labs. FDA is primarily interested in the "Primary Outcomes", which, in this case, is patient/physician scoring of mild/moderate flu-like symptoms (fever, muscle pain, cough, difficulty breathing). Secondarily, they are interested in secondary outcomes...a bunch of those here: recovery time, oxygen levels, vital signs (pulse, blood pressure, respiration rate), need for supplemental O2 etc.
Dr P would not be involved in any of this and wouldn't know anything about it. But way down at the bottom of the description of the measured outcomes are "Other Outcomes", which include Dr P's stuff: cytokine panel, RANTES, T cell profiles. These are sort of non-clinical add-ons are important for thinking about how leronlimab works, but FDA is mostly interested in whether leronlimab works.
https://clinicaltrials.gov/ct2/show/NCT04343651
Dr P would not be involved in any of this and wouldn't know anything about it. But way down at the bottom of the description of the measured outcomes are "Other Outcomes", which include Dr P's stuff: cytokine panel, RANTES, T cell profiles. These are sort of non-clinical add-ons are important for thinking about how leronlimab works, but FDA is mostly interested in whether leronlimab works.
https://clinicaltrials.gov/ct2/show/NCT04343651
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