>>If NVS’ own statements today are to be believed, the approvable letter is not due to the skin lesions seen in monkeys but rather to renal clearance.<<
But Galvus metabolizes in the liver; only inactive metabolites of it are found in the kidney, which is why they didn't do a separate study in patients with renal impairment as Merck did for Januvia -- though they did have patients in prospectively defined subsets of the PII & PIII studies: 900 of them. Merck did their primate trial with a nonselective DPP inhibitor that hit subtypes 8 & 9, too, without seeing lesions. Neither Januvia nor Galvus hit those, but Galvus caused the lesions. The doses were huge compared to the approved human doses, but it was only a 14 week study in the monkeys. NVS hasn't seen any renal tox.
No, sir, it's the lesions that are the issue. And it's likely specific to Galvus. Heh -heh maybe NVS pulled a Cortex move and botched the primate data somehow.
Regards, RockRat
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