After reading a post before it was just deleted. I
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Posted On: 04/08/2021 9:56:31 PM
After reading a post before it was just deleted. I just had to set the story straight. It was mentioned that Nader wasn’t being honest about the FDA accepting our extension results of the CD-12.
What I remember when the FDA approved our extension was the mention of only 70 people would be needed in the critical group to give us a stronger p-value and maybe a better overall mortality with some adjustments to the protocol. I haven’t looked at the possible changes that were made to the protocol. But we are approaching that number of 70 people. If we could somehow count on the 28 Philippine patients it would put us over the needed amount to achieve the results we need. Nader did say that the mortality in the 55 people was 16.7% and much better than our initial trial results. When you average it out it... maybe we have all the numbers we need to achieve an EUA.
Nader did say that the MHRA would accept the extension results and kind of stepped back from his past statement that the FDA would accept and said that hopefully they would accept the extension results. Why a step back? I don’t know...
If it’s called an extension. Then it would make sense that those results could be included or you need to change the name of what we are doing. Call it an EIND or compassionate care or something that doesn’t imply the trial is extended and adding results.
If these results are as good as we just heard (16.7% mortality) then we will have the results we needed to achieve. It was one of the 3 options Nader gave us for a fast EUA. Let’s hope another 15 people brings that number up to 70 or the patients from the Philippines do count and this all happens by the next webinar. Then maybe we can ask if they are pursuing the added results of the current extension into the CD-12 trial.
What I remember when the FDA approved our extension was the mention of only 70 people would be needed in the critical group to give us a stronger p-value and maybe a better overall mortality with some adjustments to the protocol. I haven’t looked at the possible changes that were made to the protocol. But we are approaching that number of 70 people. If we could somehow count on the 28 Philippine patients it would put us over the needed amount to achieve the results we need. Nader did say that the mortality in the 55 people was 16.7% and much better than our initial trial results. When you average it out it... maybe we have all the numbers we need to achieve an EUA.
Nader did say that the MHRA would accept the extension results and kind of stepped back from his past statement that the FDA would accept and said that hopefully they would accept the extension results. Why a step back? I don’t know...
If it’s called an extension. Then it would make sense that those results could be included or you need to change the name of what we are doing. Call it an EIND or compassionate care or something that doesn’t imply the trial is extended and adding results.
If these results are as good as we just heard (16.7% mortality) then we will have the results we needed to achieve. It was one of the 3 options Nader gave us for a fast EUA. Let’s hope another 15 people brings that number up to 70 or the patients from the Philippines do count and this all happens by the next webinar. Then maybe we can ask if they are pursuing the added results of the current extension into the CD-12 trial.
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