Let’s do some supposing...
Somebody posted these facts...
September 29, 2020 -- ~220 Enrolled
CytoDyn to Hold 2020 Virtual Annual Meeting of Stockholders
Source Link: https://edge.media-server.com/mmc/p/oofoxd3c
October 7, 2020 -- ~221 (see 3:53 in video link below)
Dr. Harish Seethamraju: “A Phase 2 Study of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)”
Source Link: https://d1io3yog0oux5.cloudfront.net/cytodyn/...tation.mp4
Note: Slide indicates 220 -- but Dr.HS verbally says around 221
The CD-12 Trial mid term analysis completed September 22nd-23rd depending on which date you use. The information on the trial was being gathered by the independent committee for independent review. The review was suppose to be a halt trial for efficacy and pass it to the FDA for review OR continue trial and keep it blinded from both the FDA and Cytodyn until trial completion.
It would appear the Cytodyn slow played adding more trial patients adding only 1 patient in 8 days OR suppose the committee forwarded the unblinded information to the FDA and the trial was stopped or better yet paused. What would this mean? FDA is suppose to only get this information if efficacy is good? Hmmm?
The talking point to dispute this efficacy stopping/pausing of the trial is the FDA and the MHRA wanted these results after seeing the CD-10 results to confirm more efficacy in trial results. These requests are not in the guidelines to request the results of future mid term analysis of other trials. Uncharted territory it would seem. What are we to believe?
Maybe it is just that the committee stopped/paused the trial as soon as the 29th or 30th for review by the FDA for efficacy. I know this sounds crazy but stay with me here.
Only one more person is added to the trial between the Sept. 29th and Oct. 7th.
That could of been the last person before the trial was stopped/paused by the committee if that is true. Fact is we don’t know. What we do know is the Dr. Harish Seethamraju said the committee and the FDA are reviewing this as we speak in his presentation. He has no reason to lead us a stray. I take it as good info that slipped out accidentally.
Some people will say that stopping of the trial information would be released immediately. What if it wasn’t? What if it temporarily was put on hold. We know that has happened with Eli Lilly. Also vaccines that have had issues and paused or on hold. What if Cytodyn entered into unofficial talks with the FDA.
I believe Remdesivir was approved 2 days after completion of their submission of trial data supporting their position. ( not that things aren’t changing right now ) what does that mean? Did they trust Gilead trial information more than our committee’s analysis and wanted to check the information themselves or together with the committee.
To many what if’s to make an assumption that there is a EUA coming Tuesday for sure.
All I am saying is we have suspect information and some true facts to go by. The reason we go over this stuff is opinions. I have a opinion and it is a positive one. It’s possible to see a EUA. It’s hopeful and possible. I won’t believe it’s not in the cards. If I was a betting person. I wouldn’t put big money on it. But
I wouldn’t dismiss the chance of a EUA.
Somebody posted these facts...
September 29, 2020 -- ~220 Enrolled
CytoDyn to Hold 2020 Virtual Annual Meeting of Stockholders
Source Link: https://edge.media-server.com/mmc/p/oofoxd3c
October 7, 2020 -- ~221 (see 3:53 in video link below)
Dr. Harish Seethamraju: “A Phase 2 Study of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)”
Source Link: https://d1io3yog0oux5.cloudfront.net/cytodyn/...tation.mp4
Note: Slide indicates 220 -- but Dr.HS verbally says around 221
The CD-12 Trial mid term analysis completed September 22nd-23rd depending on which date you use. The information on the trial was being gathered by the independent committee for independent review. The review was suppose to be a halt trial for efficacy and pass it to the FDA for review OR continue trial and keep it blinded from both the FDA and Cytodyn until trial completion.
It would appear the Cytodyn slow played adding more trial patients adding only 1 patient in 8 days OR suppose the committee forwarded the unblinded information to the FDA and the trial was stopped or better yet paused. What would this mean? FDA is suppose to only get this information if efficacy is good? Hmmm?
The talking point to dispute this efficacy stopping/pausing of the trial is the FDA and the MHRA wanted these results after seeing the CD-10 results to confirm more efficacy in trial results. These requests are not in the guidelines to request the results of future mid term analysis of other trials. Uncharted territory it would seem. What are we to believe?
Maybe it is just that the committee stopped/paused the trial as soon as the 29th or 30th for review by the FDA for efficacy. I know this sounds crazy but stay with me here.
Only one more person is added to the trial between the Sept. 29th and Oct. 7th.
That could of been the last person before the trial was stopped/paused by the committee if that is true. Fact is we don’t know. What we do know is the Dr. Harish Seethamraju said the committee and the FDA are reviewing this as we speak in his presentation. He has no reason to lead us a stray. I take it as good info that slipped out accidentally.
Some people will say that stopping of the trial information would be released immediately. What if it wasn’t? What if it temporarily was put on hold. We know that has happened with Eli Lilly. Also vaccines that have had issues and paused or on hold. What if Cytodyn entered into unofficial talks with the FDA.
I believe Remdesivir was approved 2 days after completion of their submission of trial data supporting their position. ( not that things aren’t changing right now ) what does that mean? Did they trust Gilead trial information more than our committee’s analysis and wanted to check the information themselves or together with the committee.
To many what if’s to make an assumption that there is a EUA coming Tuesday for sure.
All I am saying is we have suspect information and some true facts to go by. The reason we go over this stuff is opinions. I have a opinion and it is a positive one. It’s possible to see a EUA. It’s hopeful and possible. I won’t believe it’s not in the cards. If I was a betting person. I wouldn’t put big money on it. But
I wouldn’t dismiss the chance of a EUA.
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