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Posted On: 12/11/2020 12:14:01 AM
Post# of 148887
Cytodyn web sites CNN article about the Philippines and the Executive Order 120 signed by the Philippines president. It didn’t have a window of time included as a effective start date like some have mentioned as January 1st before the Executive Order is active. It appears to me that he signed it and it was immediately active upon his signature. There is no reference to having to wait. I looked at few articles and no start dates were included. But noticed that there was a 21 day waiting period I had not viewed in the original article for submitting EUA for review before approval.
The rules of this Executive Order were to speed up the process. Accept less trial evidence and make science based opinions on interim trial data if possible and necessary. One requirement being 50% or more trial completion.
So my thoughts are. If we complete the CD-12 trial this weekend and no unblinding is necessary any longer. Why can’t we submit our CD-10 Trial analysis and our CD-12 up to 50% interim analysis that has already been completed and possibly updated by the DSMC 2 months ago. We check all the boxes of all the requirements to submit right away and therefore will have a 21 day review as our last hoop to jump through. The only thing holding us up from our first EUA approval would be the 21 day review time after submission. Once we complete the CD-12 trial to not worry about any unblinding penalties.
So if we were ready to submit information for EUA and completed the trial this weekend. We could submit the EUA for approval this Monday IF we have it ready and we don’t use crayon to hand write the EUA submission by hand. (I’m sure we knock it out of the park!)
Time is of the essence to submit the trial information that we already have and don’t have to do anymore analysis. Then going forward we can update them on any additional analysis we can gather from the Completion of the CD-12 trial after the final analysis. Like one of the other requirements stated as a 2 month follow up with trial completion data once we complete that analysis if using early interim data for submission of the EUA.
Does this make sense as a rough timeline going forward? Let’s start that clock counting down sooner than later... life is good... and getting better...Go CYDY!
https://tribune.net.ph/index.php/2020/12/08/e...ocurement/
The rules of this Executive Order were to speed up the process. Accept less trial evidence and make science based opinions on interim trial data if possible and necessary. One requirement being 50% or more trial completion.
So my thoughts are. If we complete the CD-12 trial this weekend and no unblinding is necessary any longer. Why can’t we submit our CD-10 Trial analysis and our CD-12 up to 50% interim analysis that has already been completed and possibly updated by the DSMC 2 months ago. We check all the boxes of all the requirements to submit right away and therefore will have a 21 day review as our last hoop to jump through. The only thing holding us up from our first EUA approval would be the 21 day review time after submission. Once we complete the CD-12 trial to not worry about any unblinding penalties.
So if we were ready to submit information for EUA and completed the trial this weekend. We could submit the EUA for approval this Monday IF we have it ready and we don’t use crayon to hand write the EUA submission by hand. (I’m sure we knock it out of the park!)
Time is of the essence to submit the trial information that we already have and don’t have to do anymore analysis. Then going forward we can update them on any additional analysis we can gather from the Completion of the CD-12 trial after the final analysis. Like one of the other requirements stated as a 2 month follow up with trial completion data once we complete that analysis if using early interim data for submission of the EUA.
Does this make sense as a rough timeline going forward? Let’s start that clock counting down sooner than later... life is good... and getting better...Go CYDY!
https://tribune.net.ph/index.php/2020/12/08/e...ocurement/
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