Replies to post #1553 on Arena Pharmaceuticals, Inc. (ARNA)

[sts66]

1) Colman (the Rat) isn't the one who mixed benign and malignant tumors together, Dr. Alavi did

2) Alavi was likely driven to do that (incorrectly) when ARNA themselves reclassified some rate data in wk 96 - gave the appearance of them trying to hide something - not that it's a valid reason to do what Alavi did, but you could say he was a bit provoked and being conservative but went overboard. Not knowing the MOA didn't help either.

3) The OWG/CRO report definitely showed even better safety stats for rat tumors than what ARNA originally presented, but some margin of safety, which I forget at the moment (CSF drug levels?), actually fell to 24x, below the traditional 25x margin. Whether that's a valid issue/concern is being debated, since IIRC it only came at the highest dose (feel free to correct me if you dig up the data).

My point? Doesn't matter what MD's are saying about this or that, they have no idea what the FDA is thinking despite pure science pointing to this or that - to wit, how many believed Q would get blessed by a whopping 20-2 vote, let alone get a yes vote at all? None/not many is my guess......