Thanks for the timeline clarification; confirms what I thought, but didn't know for sure.
From the FDA docs:
"Mouse:
•
The Committee agreed that the study was acceptable, as mortality was encountered at doses higher than 50mg/kg.
•
The Committee concluded that the study was negative for any statistically significant drug-related tumor findings."
The reviewer did note the drug exposure to mice in the long term at the highest dose was equivalent to the lowest dose the rats got, though. So not sure what you mean by PROPER, as I don't see how Arena could have done it differently. But I agree, not adequate to claim the signal is specific to one species.
Anyhow, thanks again.
Regards, RockRat
