Being they didnt have the exclusion for the ccr5 d
Post# of 148093
Quote:
Being they didnt have the exclusion for the ccr5 delta 32 double allele deletion, this potentially caused less ccr5 receptors to be available for leronlimab to inhibit and possibly showed a lower efficacy in the overall trial? In other words, its possible if this exclusion was in place, the results could have shown better efficacy?
Yes, the double allele deletion would be around 1% in Caucasians so the odds of one patient being in the leronlimab arm is only around .25%. But for single allele deletion it's around 10% so odds are that 2.5 patients could patients could show up in the leronlimab arm. In a larger study of course you'd see many more patients with each mutation. The single allele patient's responses would be much lower than those who had no deletion. The FDA would certainly allow us to exclude double allele deletion patients unless they're to dumb to realize leronlimab would have no effect. Single allele they might balk at. If they do the point should be made that they're potentially keeping a drug off the market that would have a more likely chance of benefit in non-Caucasians because CCR5 deletions are far rarer in that population.