Post unblinding data collection, analysis and reporting
Note the data has to be uploaded by all trial participants while being validated for completeness, followed by analysis and reporting to the sponsor. Given some of the participants are quite busy with patient load and sick staff creating staffing and skills shortages it is a guessing game to quantify how long this step takes. Once the statistician has the top level analysis done it is given to CYDY to review and put in a reporting format and release when and where they see fit. The reporting guidelines given them significant time-frame to complete this and remain in compliance of trial reporting requirements.
My guess, 2 to 4 weeks would be great, the closer to the low side the better given the need. I would hope there is an agreement with the FDA to fast track granting of EUA if they hit the mortality end point with a statistically significant result and no significant safety issues.
Note the data has to be uploaded by all trial participants while being validated for completeness, followed by analysis and reporting to the sponsor. Given some of the participants are quite busy with patient load and sick staff creating staffing and skills shortages it is a guessing game to quantify how long this step takes. Once the statistician has the top level analysis done it is given to CYDY to review and put in a reporting format and release when and where they see fit. The reporting guidelines given them significant time-frame to complete this and remain in compliance of trial reporting requirements.
My guess, 2 to 4 weeks would be great, the closer to the low side the better given the need. I would hope there is an agreement with the FDA to fast track granting of EUA if they hit the mortality end point with a statistically significant result and no significant safety issues.
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