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Re: $heff post# 90042

Thursday, 09/03/2015 2:01:32 PM

Thursday, September 03, 2015 2:01:32 PM

Post# of 97237
Still holding SGNL also. a very solid company as well :

$13m assets vs $2m liabilities

Cash, end of period $10m

Market cap $11m

was solid as a rock in the big down market as well.

if good data/updates coming this could blow up bigtime due to the low cap and the Cash/Share ratio. imo.

Signal Genetics to Present at the Rodman & Renshaw 17th Annual Global Investment Conference,September 9, 2015.:
http://globenewswire.com/news-release/2015/09/02/765530/10147643/en/Signal-Genetics-to-Present-at-the-Rodman-Renshaw-17th-Annual-Global-Investment-Conference.html

Zacks Upgrades Signal Genetics to Buy (SGNL):

http://www.dakotafinancialnews.com/zacks-upgrades-signal-genetics-to-buy-sgnl/385184/


CARLSBAD, Calif., Feb. 2, 2015 (GLOBE NEWSWIRE) -- Signal Genetics, Inc. (Nasdaq:SGNL) (Signal), a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the U.S. Federal Drug Administration (FDA) conditionally approved its proprietary prognostic genetic test, MyPRS (Myeloma Prognostic Risk Signature®), for use as entry criteria for an upcoming clinical trial to treat high-risk multiple myeloma (MM) patients sponsored by the University of Arkansas for Medical Sciences (UAMS).

The FDA required and subsequently conditionally approved an Investigational Drug Exemption (IDE) for Signal's prognostic test in conjunction with an investigational new drug (IND) filed by UAMS for its "2012-02 Total Therapy 5B: A Phase II Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) By Applying Non-Host-Exhausting and Timely Dose-Reduced MEL-80-CFZ-TD-PACE Transplant(s) with Interspersed MEL-20-CFZ-TD-PACE with CFZ-RD and CFZ-D Maintenance" designed to improve clinical outcomes of newly diagnosed MM patients with gene expression profiling (GEP) defined high-risk disease. The Phase II trial will assess safety and efficacy for the investigational treatment regimen, using MyPRS to qualify which patients are considered to have GEP defined high risk MM. The investigation is limited to a single testing site in the United States and 45 subjects enrolled (approximately 60 subjects screened and 14 subjects enrolled per year). The conditional approval requires UAMS to provide the FDA with further information over the next 45 days; however, UAMS is allowed to begin enrollment of the trial based upon MyPRS immediately after UAMS has obtained institutional review board (IRB) approval and submitted certification of IRB approval to FDA.

Samuel D. Riccitelli, Signal's President and Chief Executive Officer, commented, "This is a significant milestone for Signal Genetics, as it brings us a step closer to our goal of gaining 'Companion Diagnostic' status for MyPRS, our novel prognostic test. In addition, we believe this is further validation of our test and its ability to aid in the treatment of multiple myeloma patients, especially during this time in which regulation and scrutiny regarding laboratory developed tests have continued to increase. We are excited to be expanding our work with UAMS, our longstanding partner, and look forward to advancing to the next stages of diagnostic development and commercialization as we work toward improving the care of patients suffering from this severe form of cancer."

Dr. Gareth Morgan, Professor of Medicine and Director of the Myeloma Institute at UAMS, commented, "We are excited to begin this Phase II trial to treat high risk multiple myeloma patients by applying more frequent, but lower doses of chemotherapy. The use of MyPRS to aid in the selection of high-risk MM patients is critical to this trial. UAMS and Signal Genetics have reached a major accomplishment and believe that with the recent IND filing and receipt of a conditionally approved IDE for MyPRS, we have demonstrated to the FDA the potential benefits of our work for the MM patient population. We also believe the new clinical trial will provide further evidence for the need of physicians to make better-informed treatment decisions in order to improve patient survival rate and quality of life."

My posts are my opinion and should not be used as investment advice. Make your own decisions in your stock trades.

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