Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[Amatuer17]

Actually dates for NDA are different -see below

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Many boards blame fda for delays but it is a govt org and still has clearly defined goals.

2 goals are key for us

1. day 74 letter - 90% of all NDA applications will undergo initial review and get a formal communication in terms of any issues with the applications and if company needs to submit additional information. If there are no issues - same will be communicated in Day 74 letter - by mail, e-mail, teleconf etc

74 days KT-302 complete on 13th Oct - so we can expect an update of NDA for next step of review by 20th Oct

2. Final review goals - 90% of NDA will undergo final review and acted upon - within 10 months - the 10 months start after 60 calendar days of the initial application date - this means 12 months of initial application date

For KT-302 - this means 31st Jul 2018

FDA also will give companies update on one late cycle review of application.

So for us as investors - wait for day 74 letter update in late Oct and possible interim update in Q1-2018 and final decision by July 2018

This will be long wait period with nearly no other action unless co finds a new partner of BO after 74 day response with no issues.