Rubraquercus, You are correct that these patien
Post# of 154684
(Total Views: 457)
Posted On: 09/30/2020 10:12:51 AM
Re: Rubraquercus #58531
Rubraquercus,
You are correct that these patients would be a good source of information for a long hauler trial design.
That does not mean that their symptoms now are sufficient in the least to demonstrate to the fda that leronlimab treats or prevents long hauler symptoms
.
The less acute the symptoms and the more subjective the observations, the more difficult it becomes to demonstrate clinical effect. This was seen in the difference between NEWS2 objective criteria and the primary endpoint criteria of patient complaints (cough, myalgia, etc).
Trial size and structures are variable based on what is being measured and treatment being applied.
Also, CD10 was phase 2 and it succeeded. FDA just is not interested in the clinical impact I’m mild patients. That is a separate issue from trial being successful.
All treated patients are a valuable source of information (ie Patterson's observation that eind patients had not blood clots and Lalezari noting no Covid in leronlimab hiv patients). But again, great staring points, not the basis to compel fda EUA or approval.
You are correct that these patients would be a good source of information for a long hauler trial design.
That does not mean that their symptoms now are sufficient in the least to demonstrate to the fda that leronlimab treats or prevents long hauler symptoms
.
The less acute the symptoms and the more subjective the observations, the more difficult it becomes to demonstrate clinical effect. This was seen in the difference between NEWS2 objective criteria and the primary endpoint criteria of patient complaints (cough, myalgia, etc).
Trial size and structures are variable based on what is being measured and treatment being applied.
Also, CD10 was phase 2 and it succeeded. FDA just is not interested in the clinical impact I’m mild patients. That is a separate issue from trial being successful.
All treated patients are a valuable source of information (ie Patterson's observation that eind patients had not blood clots and Lalezari noting no Covid in leronlimab hiv patients). But again, great staring points, not the basis to compel fda EUA or approval.
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