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Biotech / Medical : momo-T/FIF
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scaram(o)uche
To: tuck who wrote (12016)8/1/2019 4:45:18 PM
From: tuck1 Recommendation  Read Replies (1) of 12215
 
VKTX animal tox data in first half 19: not much to add wrt to "success." Clues in old Metabasis studies, perhaps?

From today's quarterly PR . . .

>> Pre-IND package submitted for VK2809; Initiation of Phase 2b NASH trial planned in 2H19. The company recently submitted a pre-investigational new drug (pre-IND) meeting briefing package to the Food and Drug Administration (FDA) for VK2809 and expects to receive written feedback from the agency in the coming weeks. A new IND is required as the existing IND is filed with the FDA's Division of Metabolic and Endocrinology Products, while most NASH drugs are reviewed in the Division of Gastroenterology and Inborn Errors Products. The company expects to file an IND application for VK2809 and initiate a Phase 2b study in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) in 2H19.<<

I would guess animal tox data is in there, but they're damned if they're going to share it with us. As a result, still no position.


Cheers, Tuck



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