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Posted On: 05/21/2020 9:07:51 AM
Post# of 148908
Wow, this has got to be one of the slowest days on the board for a long time.
I think we can all agree that the enrollment numbers expressed by NP in yesterday's ProActive video were discouraging. I can only hope that NP misspoke, because I don't think the numbers changed from last week.
There's going to have to be a sea change increase in daily enrollment for US Mild to Moderate (to get to 75), and US Severe to Critical (to get to the 50 interim) for these trials to be enrolled by the end of the May, and the results to be unblinded and submitted to the FDA by the end of the June.
Yesterday's ProActive PR for yesterday's video contains this sentence
I'd like to think we could immediately add Mexico as a new location for the two current trials, but I think that's wishful thinking.
I think we can all agree that the enrollment numbers expressed by NP in yesterday's ProActive video were discouraging. I can only hope that NP misspoke, because I don't think the numbers changed from last week.
There's going to have to be a sea change increase in daily enrollment for US Mild to Moderate (to get to 75), and US Severe to Critical (to get to the 50 interim) for these trials to be enrolled by the end of the May, and the results to be unblinded and submitted to the FDA by the end of the June.
Yesterday's ProActive PR for yesterday's video contains this sentence
Quote:Not sure we should be happy or depressed by the use of the phrase "After that..." -- because it suggests that the US Mild to Moderate might not be fully enrolled by the time the Mexico Severe trial is over. But maybe he was referring to the 390 subjects in the US Severe to Critical trial.
Pourhassan says the initial trial is expected to include about 30 patients. After that, there is potential for the NIH of Mexico to get involved in the group's two larger coronavirus trials.
I'd like to think we could immediately add Mexico as a new location for the two current trials, but I think that's wishful thinking.
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