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Posted On: 02/04/2021 12:37:16 AM
Post# of 148925
My hope is CD-12 takes only as long as CD-10 took to garner the analysis. It was almost exactly two months to the day without going back and looking at the calendar for CD-10. That’s what I remember anyway. We had the results given by Nader and I believe he was submitting them right away for what he said was a EUA but turned out to be just a question if the FDA agreed we should submit for EUA. I believe Nader didn’t want another black mark on his FDA resume.
Either way it was completed in about 60 days. We are 10 days away from about 60 days and results seem easier for mortality and yes everyone that wanted to know our mortality after unblinding probably has it right now. I am betting we are just now starting on our top line report we need for submitting for our EUA. Wether we get there or not and need that report depends on how great our mortality numbers are. If we already submitted the numbers to all concerned. The FDA and OWS could be doing some fancy logistics to help our production or they could be doing nothing. I would hope they would be doing some great things behind the scenes to help us.
Whatever happens will happen when it happens and not before. Then we will know what we have. It’s pretty exciting to know we are on the cusp of it soon. Ten days will seem like a lifetime. So maybe we get lucky and it’s only 5 or less? We can hope anyway. We should start a pool soon to see who might become closer. We use to do this. But not lately.
Either way it was completed in about 60 days. We are 10 days away from about 60 days and results seem easier for mortality and yes everyone that wanted to know our mortality after unblinding probably has it right now. I am betting we are just now starting on our top line report we need for submitting for our EUA. Wether we get there or not and need that report depends on how great our mortality numbers are. If we already submitted the numbers to all concerned. The FDA and OWS could be doing some fancy logistics to help our production or they could be doing nothing. I would hope they would be doing some great things behind the scenes to help us.
Whatever happens will happen when it happens and not before. Then we will know what we have. It’s pretty exciting to know we are on the cusp of it soon. Ten days will seem like a lifetime. So maybe we get lucky and it’s only 5 or less? We can hope anyway. We should start a pool soon to see who might become closer. We use to do this. But not lately.
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