Notwithstanding the foregoing, see “Item 3. Key Information—Risk Factors—Risks Related to Our Business, Industry and Regulatory Requirements—Our market is subject to intense competition. If we are unable to compete effectively, Aramchol or any other product candidate that we develop may be rendered noncompetitive or obsolete.”

Thanks for posting paper. Well known CR and Rapamycin different. Effect CR is to lower mTOR and increase Sirt1. Effect on Rapamycin is only reduce mTOR and no effect Sirt1. This study used sirt1 knock out mice and showed different effect. Benefits Rapamycin stand on their own evidence and nothing to do with CR. So anybody likes 30% CR, welcome to it.

According to published guidance on the SPA process, a sponsor which meets the prerequisites may make a specific request for an SPA and provide information regarding the design and size of the proposed clinical trial. The FDA has a goal of completing the majority of SPA reviews within 45 days, although certain circumstances may result in a delay in FDA’s decision. An SPA request must be made before the proposed trial begins, and all open issues must be resolved before the trial begins. If a written agreement is reached, it will be documented and made part of the record. The agreement will be binding on the FDA and may not be changed by the sponsor or the FDA after the trial begins except with the written agreement of the sponsor and the FDA or if the FDA determines that a substantial scientific issue essential to determining the safety or efficacy of the drug was identified after the testing began. There is no indication that we will be able to meet the requirements necessary for a SPA.

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We will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.

Lindy it’s post like yours that encourages Josh and community here to share information here. I would recommend Dr. Paul Rivas and Dr. Alan Green

If we, or any future collaborators, experience any of a number of possible unforeseen events in connection with clinical trials of our product candidates, potential clinical development, marketing approval or commercialization of our product candidates could be delayed or prevented.

Antisoma (LSE:ASM.L) is a biotechnology company specialising in the development of novel drugs for the treatment of cancer. Antisoma has a diverse portfolio of drugs in development

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As part of our research and development studies, we have confirmed that several Aramchol salts have improved solubility as compared to the existing form of Aramchol acid. In 2014, we submitted new patent applications to protect such salts. Should we decide to develop the formulations of Aramchol salts, we will need to conduct an appropriate bioequivalence study, or studies, of the biological equivalence of two proprietary preparations of a drug.

“Total and Cause-Specific Mortality by Moderately and Markedly Increased Ferritin Concentrations: General Population Study and Metaanalysis”

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