The Galvus extension has me dumfounded. The NVS Gallient and Glorius trials provided data for over 8000 patients, supposedly with no skin related issues. Since when does minor side effects during preclinical testing on animals warrant such caution compared to 8000 humans. The Merk Januvia trial appears to have been based on just over 2700 patients (see passage below). It would seem that preclinical animal testing concerns have been way overblown. NVS excercised caution going forward with Galvus and allowed Merk to beat them to the US market. Now it appears that FDA is looking to add to Merks cushion by allow Merk a few more months to launch ahead of Galvus. I don't like to be a conspiracy theorist but this seems suspicious.
Galvus appears to have efficacy advantage in terms of the level of blood sugar reduction. I don't know that NVS focused on the weight loss aspect whereas Merk may have to put a good spin on Januvia. The additional 3 months is a frustration but it will not be enough to trump efficacy advantages.
I realize the the link indicates that Galvus was used in combination with pioglitazone (reduces insulin resistance). Is pioglitazone likely to have improved the efficacy of Galvus?
What is your take on the delay and the potential efficacy question?
"Januvia was studied in 2,719 patients with type 2 diabetes, with follow-ups of 12 weeks to more than a year. It lowered blood sugar levels by 0.67 percent for participants in a yearlong trial, or just as much as another, older drug, glipizide. Novartis' pill, Galvus (vildagliptin), reduced blood sugar levels by 1.9 percent when used with another older drug, pioglitazone, which reduces insulin resistance "
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