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Posted On: 11/16/2020 3:22:45 PM
Post# of 148902
I don’t know if I agree with that statement to plow right to the trial end total of 390 patients. I think our numbers will only go down in comparison to the beginning of the trial. The standard of care has slowly improved and mortality has dropped in comparison.
I think Nader is hinting at unblinding the trial at 293 and getting the data as soon as possible. By asking for an exemption from the FDA to only gather data for the 14 days after completion of the trial. Not having to wait until all trial participants have met the 42 days cuts down the overall time to get our efficacy and strength in p value.
Why would Nader want that? I think it is because the DSMC saw early in the trial that deaths occurred in the placebo group Outside the 28 day mortality end point we chose. They asked us to extend it to 42 days because we couldn’t use or ad the 42 day mortality end point Unless we continued the trial. We could only ad it to the trial only if we continued the trial. The biggest group of mortality is going to be early on in the trial. We have the ability to capture the group of mortality from 28-42 days from the start of the trial by when we were continuing the trial. We accomplished that.
I believe our strength of mortality will only diminish by better standard of care going forward. In my opinion we should capture the best value we can and now might be that time. I know that strength comes in numbers in the trial. But if the mortality diminishes by better standard of care is it worth it to continue or grab the best numbers you can while you have them? Getting an exemption from the FDA for 14 days post trial saves us almost a month compared to 42 days. I have to imagine the mortality is much higher in the early trial time and we would capture the best mortality numbers by not watering down our numbers by continuing the trial. A 14 day post trial assessment would capture the largest group of people that had already accumulated the 42 day end point from early in the trial and would be a huge plus and wishful thinking. Let’s hope he can get the FDA to grant us that time saving look.
Pandemic isn’t done peaking just yet and the pressure is on for the FDA. Vyrologix could be here to save the day for many. Maybe the FDA will see what we all see when we unblind for the world to see.
I have to say I am believer in Nader and I believe he wants to unblind. I think it makes sense to do that.
I think Nader is hinting at unblinding the trial at 293 and getting the data as soon as possible. By asking for an exemption from the FDA to only gather data for the 14 days after completion of the trial. Not having to wait until all trial participants have met the 42 days cuts down the overall time to get our efficacy and strength in p value.
Why would Nader want that? I think it is because the DSMC saw early in the trial that deaths occurred in the placebo group Outside the 28 day mortality end point we chose. They asked us to extend it to 42 days because we couldn’t use or ad the 42 day mortality end point Unless we continued the trial. We could only ad it to the trial only if we continued the trial. The biggest group of mortality is going to be early on in the trial. We have the ability to capture the group of mortality from 28-42 days from the start of the trial by when we were continuing the trial. We accomplished that.
I believe our strength of mortality will only diminish by better standard of care going forward. In my opinion we should capture the best value we can and now might be that time. I know that strength comes in numbers in the trial. But if the mortality diminishes by better standard of care is it worth it to continue or grab the best numbers you can while you have them? Getting an exemption from the FDA for 14 days post trial saves us almost a month compared to 42 days. I have to imagine the mortality is much higher in the early trial time and we would capture the best mortality numbers by not watering down our numbers by continuing the trial. A 14 day post trial assessment would capture the largest group of people that had already accumulated the 42 day end point from early in the trial and would be a huge plus and wishful thinking. Let’s hope he can get the FDA to grant us that time saving look.
Pandemic isn’t done peaking just yet and the pressure is on for the FDA. Vyrologix could be here to save the day for many. Maybe the FDA will see what we all see when we unblind for the world to see.
I have to say I am believer in Nader and I believe he wants to unblind. I think it makes sense to do that.
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