IMO it was more that the FDA couldn't get behind the primary endpoint failure. Read the two FDA reps response when the question was raised about whether 80 days is just a more mature version of 50 days. They wouldn't answer. They just said there was no alpha left, and there concerns were broad, not just about the 50 day failure. That was the non-objectivity that disappointed me, and IMO was a reflection of the way the agency intended to handle the drug.
the way pazdur wanted them to hand the drug until he saw the data.
remember idmi was in the morning, a bigger market then orbec, he had his hands full turning down provenge, and Amgen epo panel the following day. until he saw the data at the panel meeting he may have known nothing about orbec, and relied on those two jerks
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