Nader said at the last webinar that we had an addi
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Posted On: 04/17/2021 7:56:35 PM
Re: ClosetInvestor #86975
Nader said at the last webinar that we had an additional 55 people in our CD-12 trial protocol. At the end of the official trial we were allowed to add more patients to our protocol by the FDA and collect additional information is my understanding. This was to allow us to strengthen our trial efficacy and P-value. Nader also said that the MHRA would accept these additional patients and hoped the FDA would also accept the added patients they approved to extend our trial protocol.
Prior to this approved “extension” it was said we would only need 70 people to achieve better efficacy and P-value. Since Nader said we had 55 in the last call. I am hoping by now we have the 70 patients. Seems reasonable to assume an additional 15 patients.
Nader also listed 3 ways for the quickest EUA and listed these additional patients. So I am assuming the extension to our CD-12 trial is the quickest way to EUA as Nader also stated.
If I am incorrect in calling it an extension and that is your issue. We have FDA approved “time” to continue to collect additional patients in our CD-12 protocol. Is this what you dispute? If it is... then you missed a bunch of talking points that have been brought up since we released the original trial results.
Prior to this approved “extension” it was said we would only need 70 people to achieve better efficacy and P-value. Since Nader said we had 55 in the last call. I am hoping by now we have the 70 patients. Seems reasonable to assume an additional 15 patients.
Nader also listed 3 ways for the quickest EUA and listed these additional patients. So I am assuming the extension to our CD-12 trial is the quickest way to EUA as Nader also stated.
If I am incorrect in calling it an extension and that is your issue. We have FDA approved “time” to continue to collect additional patients in our CD-12 protocol. Is this what you dispute? If it is... then you missed a bunch of talking points that have been brought up since we released the original trial results.
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