Replies to post #143366 on Biotech Values

[DewDiligence]

I hadn't realized that. But they are pretty much obliged to dose according to the label in a trial even if that isn't the de facto standard.

In this instance, Roche might have been able to dose Humira using the de facto standard because the language in the FDA label leaves some wiggle room about weekly dosing w/o methotrexate.

Clearly, however, it was in Roche’s interest to under-dose the Humira patients in the ADACTA study, so that’s what they did. Most pharma companies would probably have done the same.

[DewDiligence]

Approximately how far behind Tofacitinib is INCY/LLY’s RA drug?

[DewDiligence]

According to Roche, the (biased) Actemra-vs-Humira study we recently discussed was the first head-to-head trial of two biologics in RA. I knew there hadn’t been many such trials because most drug/biotech companies hate them, but I hadn’t realized that this was the first.