This is what will make approval of the dosing level somewhat difficult. May be another Ph 3 trial to further stratify the data? Don’t know, but it will cause Glickman heartburn..
Difference In Efficacy Between Men and Women
In the sub-set analysis presented by Dr. Solomon, there was an interesting sex difference. Albeit there were a very small number of men in the entire study (35 males out of 265 patients), women achieved a 36% CR rate in the low dose arm compared to 26% in the high dose arm. However, men achieved a 15% CR rate in the low dose arm versus a 43% CR rate in the high dose arm.
A In the sub-set analysis presented by Dr. Solomon, there was an interesting sex difference. Albeit there were a very small number of men in the entire study (35 males out of 265 patients), women achieved a 36% CR rate in the low dose arm compared to 26% in the high dose arm. However, men achieved a 15% CR rate in the low dose arm versus a 43% CR rate in the high dose arm.
Perform a do over to do a Phase 3b trial to determine dosages for men and women? Or, get the label right for women first??
Perplexing results to say the least.. may be a phase 3b trial will be needed to stratify the results? Or, approve for women first, then a phase 3b trial for men to optimize the dose? FDA to pull out their hair on this one???
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