I thought double allele and single allele deletion

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I thought double allele and single allele deletions were only (respectively) 1% and 9% of the European population, and therefore would be even less than that in the U.S. Why would the FDA forbid an exclusion of a fairly small percentage of the population?

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The FDA would have no problem with double allele because obviously leronlimab would have no effect. Single allele it would have some effect so the FDA might consider the exclusion of those people unnecessary. With both excluded there would be a stronger statistical significance and on approval and money flowing a follow-up trial could be done with single allele patients. But the FDA does not always follow a logical path or one that benefits small pharmaceuticals.