Replies to post #106916 on Biotech Values

[DewDiligence]

I have to edit the 2010 FDA-approval table again—forgot about Vivitrol.

[biomaven0]

included one set of data suggesting that higher exenatide levels might prolong the QTc interval

I've seen the scatter plot of the data points (QTc vs drug level) and they are all over the place. The fact that a regression line through the points turned out to be ever-so-slightly upward sloping looks more like bad luck than anything else. (If you have a slightly positive slope and you extrapolate to much higher doses, then eventually you do get to a region of moderate concern).

(Personally I've always thought the FDA obsession about marginal QTc increases is a case of a drunk looking for the money under a streetlight instead of where he dropped it because that's where the light is. It's an easily measurable safety issue they can easily fuss about and of course they got burnt in earlier years with big QTc increases from drug-drug interactions.)

Peter