If they received a 483 for manufacturing issues, that is material IMHO.
I love this argument by assertion. I consider maharajah's opinion cogent and useful because he gave facts and insight - albeit facts that don't seem to fully jibe with 7000 given per year? But all of this argument by assertion seems silly.
Most of the realistic longs realized there was a meaningful likelihood of approval with a relatively quick to fix cmc issue. And that would have been considered a home run or at least a triple.
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