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Posted On: 06/08/2019 5:06:34 PM
Post# of 154142
Thanks for posting.
This trial was a randomized phase 2 with a total of 165 patients between the two arms. From briefly reading the information on the trial, survival was the main endpoint. My guesstimate is the time from the start of the phase 2 trial until accelerated approval was 24 months, give or take a few months, maybe longer.
Hopefully CTC levels and tumor size will both be decided and that will enough for accelerated approval. The question is will the FDA require a larger, randomized phase to conform the findings?
This trial was a randomized phase 2 with a total of 165 patients between the two arms. From briefly reading the information on the trial, survival was the main endpoint. My guesstimate is the time from the start of the phase 2 trial until accelerated approval was 24 months, give or take a few months, maybe longer.
Hopefully CTC levels and tumor size will both be decided and that will enough for accelerated approval. The question is will the FDA require a larger, randomized phase to conform the findings?
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