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Posted On: 07/05/2020 9:49:22 AM
Post# of 155047
Regarding what is known due to blood tests in the CD12 trials, there are some uncertainties:
- you may recall in the first 10-12 eIND severe/critical patients the blood samples were not provided for all the patients consistently. Probably too cumbersome and disruptive depending on the patients situation. Remember some may be in ventilators, etc...
- this CD12 trial endpoints do not need blood tests
- my guess is that there maybe blood samples passed to Dr BP based on some (not all) consent grants but not 100% of the patients
- which leads to a lot of uncertainty in the comparison of the placebo arm versus the therapeutic arm participation numbers.
- Upon unblinding, any blood samples that were analyzed would provide useful data to study the disease and this would be the primary motivation.
Lastly, I got the feeling that when the more cumbersome CD10 data is fully analyzed, they will then stop the CD12 trial and unblind these results as well. The number of patients fully treated, at that point, will be greater than 120 but the data compiling and analysis will be trivial as the endpoints are mortality counts only. Hence NP’s statement we will submit data from both trials simultaneously to the FDA makes sense to me.
- you may recall in the first 10-12 eIND severe/critical patients the blood samples were not provided for all the patients consistently. Probably too cumbersome and disruptive depending on the patients situation. Remember some may be in ventilators, etc...
- this CD12 trial endpoints do not need blood tests
- my guess is that there maybe blood samples passed to Dr BP based on some (not all) consent grants but not 100% of the patients
- which leads to a lot of uncertainty in the comparison of the placebo arm versus the therapeutic arm participation numbers.
- Upon unblinding, any blood samples that were analyzed would provide useful data to study the disease and this would be the primary motivation.
Lastly, I got the feeling that when the more cumbersome CD10 data is fully analyzed, they will then stop the CD12 trial and unblind these results as well. The number of patients fully treated, at that point, will be greater than 120 but the data compiling and analysis will be trivial as the endpoints are mortality counts only. Hence NP’s statement we will submit data from both trials simultaneously to the FDA makes sense to me.
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