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Replies to post #4012 on Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)
09/28/16 1:47 PM
To summarize, Kitov is lead by an ex-FDA team where the chemist, the pharmacologist and the physicians all worked for the FDA. We know the process, we know how to use it.
Our lead candidate has finished its clinical trials. They were all successful. For our efficacy study, the p-value for the primary end-point was 0.001.
We are entering a multi-billion dollar market. Non-steroidals are the most widely consumed class of medication on the planet, when you combine prescription and OTC. That's what we're entering, and we will be the only non-steroidal on the market who can claim we are indicated to prevent heart-attack, stroke, and death.
We are entering the FDA using the 505v2 process that allows us to utilize previous NDAs. We are entering it with a protocol that was not only successful, but was approved through the SPA process.
We have recently been issued a patent that will run through 2030 -- much more patent protection duration-wise than most biotech companies' drugs when they enter the market.
And we expect to submit our NDA with 6 months.
09/29/16 11:03 AM
