I'd say some manufacturing issue would be the most likely possible holdup/screwup. The FDA doesn't want an aircraft through its window too, so my guess is they are going to be inclined to overlook any minor manufacturing deficiencies though.
But demand will be simply enormous, and even if some doctors don't believe it works, they will have no alternative but to prescribe it.
Sure a $4B market cap doesn't look cheap - but then CELG has a $27B market cap. So a pretty dangerous short in my view.
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