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Posted On: 01/09/2021 2:49:26 PM
Post# of 148899
It was a long process (but not abmormal), not the 1-2 days people keep posting about on here.
June 11: Reached Complete Enrollment w/Primary Endpoint 14 after
June 25: Start of Unblinding "SHOULD HAVE" Occurred (but no update provided by Cytodyn)
July 13 (~18 past the point of process to unblind data): CytoDyn is planning to lock and unblind the Phase 2 COVID-19 trial data later this week.
*so basically it took 3 weeks after the final patient reached completion of P.E. before announcing unblinding
July 21 (~26 past the last pt reaching 14 day P.E., and ~8 past The July 13 PR stating unblinding to occur that week): Cytodyn Announces ONLY SAE Data, nothing else - "Evaluation of safety data indicates the following"
August 11 (~47 past the last pt reaching 14 day P.E. and 21 days past release of only SAE data): CytoDyn Announces Clinically Significant Top-line Results
In short, Cytodyn must accomplish the following for our upcoming CD12 Release:
1) after last pt has gone 28 days, the Principal Investigator at each of our trial sites has to verify and validate the data.
2) then the P.I. must Sign Off on data then Lock Data. Each trial site may take varying amounts of time to complete based upon any number of factors affecting workload.
3) I don't believe the trial sites can send the data to Cytodyn/Amarex though until ALL trial sites have signed off and locked data (but would need to verify that statement for accuracy)
4) Unblinding will occur after ALL Sites have signed, locked, and transmitted data
5) Amarex will begin Analysis of Data. For CD12, this will not necessarily be as simple as counting number of deaths, but rather Analysis needs to be performed on cause of death as well.
6) I have no clue how long process will take with CD12 vs CD10. It could easily follow the same timeframe for the time it took to sign, lock, and unblind data, which was 26 days past last pt reaching P.E., but I also wouldn't place a bet on that. My guess is the process will be much faster this time around. How fast I'm not sure. Can't imagine we will wait 26 days again for SAE events, but I'm hopeful for 7 days. Exciting times are in store.
**Anyone that has more specific steps for the process, please share. Thanks!
June 11: Reached Complete Enrollment w/Primary Endpoint 14 after
June 25: Start of Unblinding "SHOULD HAVE" Occurred (but no update provided by Cytodyn)
July 13 (~18 past the point of process to unblind data): CytoDyn is planning to lock and unblind the Phase 2 COVID-19 trial data later this week.
*so basically it took 3 weeks after the final patient reached completion of P.E. before announcing unblinding
July 21 (~26 past the last pt reaching 14 day P.E., and ~8 past The July 13 PR stating unblinding to occur that week): Cytodyn Announces ONLY SAE Data, nothing else - "Evaluation of safety data indicates the following"
August 11 (~47 past the last pt reaching 14 day P.E. and 21 days past release of only SAE data): CytoDyn Announces Clinically Significant Top-line Results
In short, Cytodyn must accomplish the following for our upcoming CD12 Release:
1) after last pt has gone 28 days, the Principal Investigator at each of our trial sites has to verify and validate the data.
2) then the P.I. must Sign Off on data then Lock Data. Each trial site may take varying amounts of time to complete based upon any number of factors affecting workload.
3) I don't believe the trial sites can send the data to Cytodyn/Amarex though until ALL trial sites have signed off and locked data (but would need to verify that statement for accuracy)
4) Unblinding will occur after ALL Sites have signed, locked, and transmitted data
5) Amarex will begin Analysis of Data. For CD12, this will not necessarily be as simple as counting number of deaths, but rather Analysis needs to be performed on cause of death as well.
6) I have no clue how long process will take with CD12 vs CD10. It could easily follow the same timeframe for the time it took to sign, lock, and unblind data, which was 26 days past last pt reaching P.E., but I also wouldn't place a bet on that. My guess is the process will be much faster this time around. How fast I'm not sure. Can't imagine we will wait 26 days again for SAE events, but I'm hopeful for 7 days. Exciting times are in store.
**Anyone that has more specific steps for the process, please share. Thanks!
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