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Posted On: 04/15/2020 6:31:06 PM
Post# of 153917
Quote:
Its not because we havent been able to have widespread testing to determine the actual fatality rate. And we wont for a long time.
??? We do not have the fatality rate ??? Make a test. Go to any N.Y. hospital and check their records: patients entered, conditions, treatment, response, outcome. All there. Only one busy hospital could provide all the data you need for a reference cohort.
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That's not why the fda does placebo based trials. They need to be able to state factual data (ie. 81% of the placebo group did not show a reduction in the cytokine storm, where as 92% of the leronlimab group showed improvement)
I beg to disagree. The Primary outcome of the Severe trial is only one: Survival day 28.
https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=3
Even the secondary outcomes (for reference) will be well registered in hospitals as part of their clinical routine. Patients are very closely followed up by our excellent health care providers.
Cytokine storm measurements are not part of the trial. All is needed (from the control cohort) is the probability of success which is the input to the binomial distribution model that FDA will use to ascertain if the p-number is less than 0.05 meaning that the results are statistically significant whiting certain confidence level.
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