Trial failures? I'm not aware of a single failed
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Posted On: 02/24/2021 3:13:54 PM
Trial failures? I'm not aware of a single failed trial.
Are you referring to CD10? If so, CD10 was an overwhelming success. The purpose of a phase 2 trial is to determine the best endpoint for a phase 3 trial, as well as any modifications to the trial. We have not yet decided to pursue phase 3 because it is clear that this will be the last group to get approved.
But the CD10 trial identified the best PE for a phase 3 trial. NEWS2 score. Not only did it identify the best endpoint, it actually hit statistical significance. Which, with a small phase 2 trial is actually quite remarkable.
They also realized that if they excluded patients that were barely symptomatic the data would improve significantly.
I have no doubt in my mind that if they built and pursued a phase 3 trial with several hundred patients it would hit its Primary Endpoint.
So, Ill ask. Why do we think that CD12 may not hit its PE?
This is all in my opinion, but it seems to me that all indications are still pointing in the same direction.
Are you referring to CD10? If so, CD10 was an overwhelming success. The purpose of a phase 2 trial is to determine the best endpoint for a phase 3 trial, as well as any modifications to the trial. We have not yet decided to pursue phase 3 because it is clear that this will be the last group to get approved.
But the CD10 trial identified the best PE for a phase 3 trial. NEWS2 score. Not only did it identify the best endpoint, it actually hit statistical significance. Which, with a small phase 2 trial is actually quite remarkable.
They also realized that if they excluded patients that were barely symptomatic the data would improve significantly.
I have no doubt in my mind that if they built and pursued a phase 3 trial with several hundred patients it would hit its Primary Endpoint.
So, Ill ask. Why do we think that CD12 may not hit its PE?
This is all in my opinion, but it seems to me that all indications are still pointing in the same direction.
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