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BRIEF-Kitov pharmaceuticals announces receipt of FDA's favorable response to NT219's pre-ind meeting package
November 1, 2017 / 1:33 PM / 2 months ago

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

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 Source text for Eikon: Further company coverage: (Bangalore.newsroom@thomsonreuters.com)

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