Edition:
India

Kitov pharmaceuticals announces receipt of FDA's favorable response to NT219's pre-ind meeting package


Wednesday, 1 Nov 2017 

Nov 1 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov Pharmaceuticals announces receipt of FDA's favorable response to NT219's pre-ind meeting package.Kitov Pharmaceuticals - U.S. ‍FDA agreed to proposed Chemistry Manufacturing, Controls (CMC), preclinical, clinical development plans for NT219​.Kitov Pharmaceuticals Holdings Ltd - U.S. ‍FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support ind​.Kitov Pharmaceuticals Holdings Ltd - U.S. ‍FDA further agreed that no toxicology studies of NT219 together with Gemcitabine would be necessary​.Kitov Pharmaceuticals Holdings Ltd - ‍expect to submit ind with FDA for NT219​ during first half of 2019. 

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