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Jeff Ramson
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Founder and CEO of ProActive Capital Resources Group (PACRG), LLC, - over 25 years trading and investing. I employ technical analysis combined with discretionary analysis of global events and trends. I am equally comfortable from either long or short side of the markets. Owner of... More
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  • TNXP Tonix Pharma: Developing Improved Neurological Drugs For Better Patient Outcomes 1 comment
    Aug 16, 2012 8:47 AM

    ProActive Capital Resources Group has received compensation from TONIX, to provide research and investor relations coverage for a period of time.

    Tonix Pharma (NASDAQ:TNXP) is a specialty pharmaceutical company focused on the development of improved formulations of drugs for common central nervous system (NYSE:CNS) disorders such as lead product candidates TNX-102 andTNX-105 which are based on the widely used muscle relaxant drug cyclobenzaprine (aka FLEXERIL, AMRIX and FEXMID).

    TNX-102 SL is a sublingual (under the tongue) low-dose (2.4mg) formulation of cyclobenzaprine with a pivotal Phase 3 clinical trial expected to begin early next year for the treatment of fibromyalgia (to help restore normal sleep patterns), which affects an estimated 5 million Americans according to National Institute of Health (NIH) stats and represents a US market opportunity of $1.4 billion. The Company recently announced the results of Phase 2 clinical trials demonstrating a faster onset via sublingual administration along with reduced levels of a metabolite (norcyclobenzaprine) compared to standard table formulations of the drug.

    Cyclobenzaprine is widely used off-label for the treatment of fibromyalgia so there is a significant market opportunity for $TNXP to develop an improved version of the drug and perform pivotal Phase 3 testing to obtain formal FDA approval for this indication. $TNXP has demonstrated lower levels of norcyclobenzaprine that support long-term dosing at bedtime for the Company's sublingual formulation (TNX-102) since this metabolite is known to have activity and accumulates over time.

    $TNXP is also developing TNX-105 as an additional very low dose cyclobenzaprine (VLDC) novel formulation for the management of post-traumatic stress disorder (PTSD) and plans to conduct a proof-of-concept clinical trial during the first half of 2013. The Company expects to complete the first of two planned pivotal Phase 3 trials for TNX-102 during 1H14 and plans to seek a partnership for the second pivotal study and commercialization.

    Given the demonstrated advantages for lead product candidateTNX-102 and the greatly reduced clinical risk as an improved formulation of an existing drug; shares of $TNXP are poised to gain attention from traders in the biomedical space as the Phase 3 trial begins given the substantial market opportunity in the lead indication for fibromyalgia.

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  • SkyPilot0000
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    Good management advancing the development of non-addictive drugs for chronic pain.
    7 Oct 2012, 11:07 AM Reply Like
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