What "seems to be happening here is there is a much more business approach which is, well, we don't really want to know what happens," he said. "Because if we know, then there are commercial implications."
For Plan II, they also discussed the "problem" and stated: "A positive finding in the Japanese style Segment II study would be more of a problem since in this case it is undoubtedly exposure during early pregnancy that is of concern for women."
"A strengthening of the labeling might be likely, EG, women of childbearing potential should not take the drug unless they know they are not pregnant and are taking adequate contraceptive precautions," they warned. "Worst case, but just possible, contraindication of women of childbearing potential."
"What they're saying here is that an awful lot of women clearly don't know they're actually pregnant until a few weeks into the pregnancy," Healy had explained earlier, regarding what was meant by "contraindication" for women in childbearing years.
"Those early few weeks are the period when the harms may happen," he said. "And in the case of a drug like this where ... there may be a risk of being hooked to the drugs so you cannot get off it if you think you may have become pregnant, then clearly this all becomes extremely risky as it goes on."
And in this paragraph, they reiterated: "Again, a change in U.S. Pregnancy category from B to C is likely."
"A positive in the Japanese Segment III would be less of a problem," they wrote, "since it defines the critical period as the third trimester which authorities would feel more comfortable with."
"However," they warned, "they may insist on animal findings being added to the labeling with additional comments and this is certainly the case with the United States, Canada and Australia who have extensive product information."
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