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Posted On: 06/17/2020 10:02:19 AM
Post# of 154138
TechGuru,
Yes, I completely understand the power of a double whammy.
However, my last comment in that post was that I could find no direct reference in the P3 S/C protocol that indicated that there was an interim look -- or that it had to take place at the threshold of 50 subjects. So, why not delay both, and get both of them closer to 100?
Speaking only for myself, I'd rather have a delay of 2 weeks on both trials -- than a delay of 2 months for a new and much larger P3 M/M, and a demand to finish the 390 subjects in the P3 S/C -- especially with a patient base that is possibly dwindling.
Yes, I completely understand the power of a double whammy.
However, my last comment in that post was that I could find no direct reference in the P3 S/C protocol that indicated that there was an interim look -- or that it had to take place at the threshold of 50 subjects. So, why not delay both, and get both of them closer to 100?
Speaking only for myself, I'd rather have a delay of 2 weeks on both trials -- than a delay of 2 months for a new and much larger P3 M/M, and a demand to finish the 390 subjects in the P3 S/C -- especially with a patient base that is possibly dwindling.
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