(Total Views: 513)
Posted On: 02/16/2021 11:51:20 AM
Post# of 148893
Re: generactor #78104
"Those patients are from the aviptadil expanded access study. They were very, very ill, too ill to qualify for the clinical trial. That's why the mortality rate was so high and shouldn't be seen as indicative as to what happened during their clinical trial."
The 35 placebo patients were not expanded access.
The placebo patients were either part of the clinical trial (n=11) or "concurrent standard of care controls" (n=24) which made up a total of 35 placebo patients.
11 of the 35 placebo patients were not the "sickest of the sick" because those 11 were healthy enough to qualify for the aviptadil trial.
The other 24 placebo patients could indeed have been so sick that they did not qualify for the trial and thus died more quickly.
The BRPA SEC filing has some odd language that implies US federal government OWS requested an interim report from RLFTF, and that interim report should include at least 1) first 21 patients in the randomized clinical trial, 10 of whom were treatment and 11 were placebo, and 2) "concurrent standard of care controls" of which there were 24 reported in the BRPA SEC filing.
The 35 placebo patients were not expanded access.
The placebo patients were either part of the clinical trial (n=11) or "concurrent standard of care controls" (n=24) which made up a total of 35 placebo patients.
11 of the 35 placebo patients were not the "sickest of the sick" because those 11 were healthy enough to qualify for the aviptadil trial.
The other 24 placebo patients could indeed have been so sick that they did not qualify for the trial and thus died more quickly.
The BRPA SEC filing has some odd language that implies US federal government OWS requested an interim report from RLFTF, and that interim report should include at least 1) first 21 patients in the randomized clinical trial, 10 of whom were treatment and 11 were placebo, and 2) "concurrent standard of care controls" of which there were 24 reported in the BRPA SEC filing.
(1)
(0)
Scroll down for more posts ▼