Arena Pharmaceuticals, Inc. (ARNA)

[ferretmoney]

The rat cancers occurred in statistically significant numbers only at an extremely high dose, higher than the FDA's safety margin of 25x. They should not have been a concern and the company stated that they and the FDA considered the rat tumors not a concern for humans. The benign mammary tumors the female rate grew at elevated doses are normal for rats. They get benign mammary tumors from too much water. They are highly sensitive to changes in their bodies and grow tumors from any disturbance. The mechanism is generally considered not translating to humans.

So nobody missed anything. The FDA torpedoed the panel discussion with a non-issue by combining benign and cancerous tumor numbers and only then getting numbers that were statistically significant, and to ensure that the torpedo would explode they stacked the panel with NO EXPERTS who could speak to the rat cancer non-issue with scientific credentials.