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Stock Judge

04/03/19 2:17 PM

#2885 RE: Patience 1 #2884

TRUMP 2020 & 2024!!!
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LiquidAdventure

04/03/19 2:58 PM

#2886 RE: Patience 1 #2884

Agreed, the stock will not move up until more positive news is released. However, the next news looks doesn't look so swell. From page 8 of the Company's 10-k:

In September 2017, we contracted Stockholm South General Hospital in Sweden to conduct a Phase 2 study of our topical Endoxifen in women with high MBD. The study is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The primary endpoint of this pilot study is to determine if topical Endoxifen results in an individual reduction of MBD as measured by mammography. Secondary endpoints include demonstrating safety and tolerability. The primary objective is to determine the effect size of breast density between placebo and topical Endoxifen to permit sample size calculations for statistical significance in a future Phase 3 trial. The study was fully enrolled in October 2018 with 90 participants who were equally randomized to three different groups (30 per group): placebo; lower dose topical Endoxifen; and higher dose topical Endoxifen. Participants receive the active drug or placebo for a maximum of six months. The study calls for each participant to have a baseline (pre-treatment) mammogram, and additional mammograms at month 3 and 6, or at the time of study exit. Once the study has been completed, all mammograms will be interpreted and MBD determined and any changes that occur per patient recorded. Some participants have chosen to exit the study before receiving a full six months of drug or placebo for a number of reasons: for example, some exit for non-compliance with the study protocol and some have exited because of skin rashes and irritation. As of the date of this annual report, approximately 72 participants have exited the study primarily because of skin rashes and irritation. Because the study is double blinded and results-to-date are not known, we do not know how or if the fact that some study participants exited the study before six months of dosing will result in sufficient data to achieve the primary objective which is to design a subsequent study. We expect that all dosing in the study will be completed in April 2019 with preliminary result to be reported in the second quarter of 2019.

With 80% of the participants exiting the study early, how can this be anything but bad news?

Another possible news item can be found on page 74:

On January 13, 2019, the Company granted a new option to the CEO to purchase 2,300,000 shares of Common Stock and a new option to the CFO to purchase 800,000 shares of Common Stock (the “2019 Options”). The 2019 Options: (i) have an exercise price equal to the fair market value of Common Stock on the date of grant which was $1.36 per share, (ii) do not contain a Net Cash Exercise provision, (iii) are granted pursuant to the terms and conditions of the Plan as amended by the Board of Directors on January 13, 2019, to include shares issuable upon exercise of the 2019 Options and other changes to the Plan so that the 2019 Options do not conflict with the Plan (the “Amended Plan”), (iv) vest and are exercisable in accordance with the vesting schedule related to the 2018 Liability Options; provided, however, that the 2019 Options are not exercisable unless and until the Company’s stockholders approve the Amended Plan to increase the authorized number of shares available for grant under the Plan as only 3,575 options were available for grant as of December 31, 2018, and (vi) are subject to and conditioned the 2019 Option Agreements with the optionees and the employment agreements with the optionees.

The annual meeting proxy (due out any day) will most likely contain a provision for a shareholder vote on the 2019 Options. From page 2 of the 10-k, "The number of shares outstanding of the registrant's common stock, par value $0.18, as of March 25, 2019 was 9,116,490." How is the market going react to a 34% dilution request with zero cash raised to further the company's clinical trials?