Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[finesand]

SEC assisting ISA's old Investigation for Information - Non Event

- PR http://globenewswire.com/news-release/2018/09/18/1572676/0/en/Kitov-Pharma-Updates-on-Motions-in-USA-Initiated-by-Kitov-Chairman.html

- SEC Enforcing Information Request https://www.sec.gov/litigation/litreleases/2018/lr24271.htm

- The Memo https://www.sec.gov/litigation/litreleases/2018/lr24271-memo.pdf

From KTOV PR

As stated by the SEC, “The application does not reflect a determination by the SEC or its staff that Waymack or Kitov Pharmaceuticals has violated any provisions of the federal securities laws or any provisions at issue in the Israel Securities Authority's investigation”. The formal order issued by the SEC, which authorizes the SEC Staff to issue subpoenas and take testimony, states that the Israel Securities Authority (“ISA”) has requested assistance in connection with an investigation and does not cite any other reason for issuing the formal order. Furthermore, counsel for the SEC has confirmed to Dr. Waymack’s counsel that the sole purpose of the SEC’s involvement in this matter is to facilitate obtaining documents and testimony from Dr. Waymack on behalf of the ISA, pursuant to the assistance memorandums between the SEC and ISA, which, as previously announced by Kitov, is conducting an ongoing investigation of Kitov and certain of its principals.

- Old ISA investigation has been known
- SEC is 'helping out' with ISA's information request
- Waymack delayed the cooperation w/ SEC, he doesn't believe ISA is 'authorized'.
- SEC moved the request to a legal format, on court via the subpoena. Now all parties may debate (o8>

From Memo, SEC counsel

As we show there, SEC administrative subpoenas are not self-executing subpoenas – that is, for them to be enforced the SEC must first file a subpoena enforcement application in federal court. Consequently, pre-enforcement challenges to such subpoenas are not permitted.

Most important, what is all this ISA investigation all about?

From KTOV PR

Kitov believes that the ISA’s concerns are misguided and not consistent with industry accepted U.S. Food and Drug Administration (“FDA”) regulatory requirements, nor with the procedures for the conduct of clinical trials for the purposes of New Drug Application submissions to the FDA. Furthermore, Kitov believes that the ISA is not the regulatory body authorized to evaluate the materiality of events and the completeness of public disclosures made by us in compliance with United States federal securities laws.

In addition, Kitov strongly disputes the legal ramifications of any possible concerns of the ISA with respect to its disclosures in these matters. Kitov firmly believes that the information relating to the post-trial internal dissemination of the statistical analysis of the Phase III clinical trial data of Consensi™ is not material, and was not material at the time of the Company’s announcement of the final clinical trial results. This matter had no impact whatsoever on the validity of the analysis of the Consensi™ Phase III clinical trial data, which successfully met its primary efficacy endpoint with statistical significance. In addition, the statistical analysis was further validated by the Consensi™ Phase III/IV renal function clinical trial data, which had a similar primary efficacy endpoint. Finally, the statistical analysis was included in the final Phase III clinical study report which was part of Kitov’s NDA submission for Consensi™ subsequently filed and approved for marketing by the FDA in May 2018.

Kitov has previously announced commercialization agreements for Consensi™ with leading pharmaceutical companies in China and South Korea, and is focused on securing an optimal U.S. commercialization partner for Consensi™ in the U.S.

Bottom line: No news here to see, but thanks for the dip (o8>
You also might have noticed that we closed 2c above $1.65 and marked a double or triple bottom today.
SSR until 9/19 EOD and TASE back on 9/20, which exchange will close this hilarious gap has to be seen (o8>

Here the conservative valuation. Please note that
- FDA approval has already been given
- China and Korea deal signed-off already (SP should be $2.40)
- US deal coming up