I know you never said you did, thats why asked you
Post# of 155045
(Total Views: 491)
Posted On: 05/28/2020 10:51:22 AM
I know you never said you did, thats why asked you what you meant by your statement, hence the '?'
Out in the cold is one way to put it, not how I would though. The limited enrollment due to patients not meeting the inclusion criteria (or meeting 1 of the exclusion criteria) is very much likely the artifact of Cytodyn's trial design. So to answer your question, yes, I "blame" Cytodyn, but I'm not angry with them. This doesn't make Cytodyn a bad company or the design of the trial flawed, it makes things par for the course. You can meet the inclusion criteria but be excluded because you also meet 1 or more of the exclusion criteria. Creating stricter inclusion/exclusion criteria is done by companies to improve the chance of success. Within reason if a company wants to use a wide spectrum for its patient population, the FDA isn't going to say no. I will also add that Cytodyn has made changes to its exclusion criteria since the first patient was injected. Leading me to believe they were the ones limiting access to a certain patient population and realized at least some of the slowed enrolled was their fault.
Slow enrollment is no doubt frustrating, but when you have limited resources, compete with BP trials and a "SOC", its an extremely unfortunate reality. These challenges exist in trials outside of the COVID world and we've seen it.
Out in the cold is one way to put it, not how I would though. The limited enrollment due to patients not meeting the inclusion criteria (or meeting 1 of the exclusion criteria) is very much likely the artifact of Cytodyn's trial design. So to answer your question, yes, I "blame" Cytodyn, but I'm not angry with them. This doesn't make Cytodyn a bad company or the design of the trial flawed, it makes things par for the course. You can meet the inclusion criteria but be excluded because you also meet 1 or more of the exclusion criteria. Creating stricter inclusion/exclusion criteria is done by companies to improve the chance of success. Within reason if a company wants to use a wide spectrum for its patient population, the FDA isn't going to say no. I will also add that Cytodyn has made changes to its exclusion criteria since the first patient was injected. Leading me to believe they were the ones limiting access to a certain patient population and realized at least some of the slowed enrolled was their fault.
Slow enrollment is no doubt frustrating, but when you have limited resources, compete with BP trials and a "SOC", its an extremely unfortunate reality. These challenges exist in trials outside of the COVID world and we've seen it.
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