Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[tykundegex]

The one that successfully applied for and was granted a $2 million waiver for the NDA filing fee
The one that ran a trial that met FDA's bioequivalence requirements.
The one whose members include:
* a former FDA medical officer, with over 20 years experience as a drug development consultant for major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle, and
* a former FDA chemist with over 15 years experience in drug development and consulting for multinational and emerging biotech and pharma companies

I think they'll manage to file the NDA just fine, without rejection.

The investigation seems to have come about from a legitimate concern, but doesn't appear at this stage that anything negative will come of it.