This is Michael Fossel you are talking about Alan, Telocyte is not a con. He has intentionally selected a trial on full blown, not early onset, Alzheimer’s to blow the whole FDA stance on aging wide open. Plus Alzheimer’s is basically the most horrible disease of aging. His approach is diametrically opposite to yours Alan because he is trying to restore gene expression to youthful levels, which entails some speeding things up, notably the metabolic digestion of aggregate proteins by glial cells, which is where his confidence comes from that this will work. He is aiming to start trials next year, but this is dependent on the FDA accepting some of Blasco’s mouse work.

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I love doing those sort of experiments, I’ve learnt a lot simply by playing around with cycling supplements or even simple dietary changes. Many of my discoveries have been accidental.

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.

Xia, W., Yin, Z., Li, J., Song, Y. & Qu, X. Effects of rosuvastatin on asymmetric dimethylarginine levels and early atrial fibrillation recurrence after electrical cardioversion. Pacing and clinical electrophysiology ACE 32, 1562–1566, doi:10.1111/j.1540-8159.2009.02554.x (2009).

In 2016, the U.S. Congress enacted the 21st Century Cures Act. The law contains several provisions aimed at accelerating drug approval. In particular, it directs FDA to implement a formal review pathway to qualify biomarkers and other drug development tools. It is unclear when this new pathway will be implemented or whether using this pathway would have any impact on our clinical program.

On October 6, 2016, we initiated a proof-of-concept 20-week, double blind, controlled study to evaluate the efficacy and tolerance of Steamchol (a synthetic FABAC, a conjugate of stearic acid (C18:0) and colic acid with similar properties of Aramchol formulated as topical cream), in subjects with Acne Vulgaris. The study was conducted at the IRSI Institute (International Research Services Inc.) in Port Chester, New York, US. A total of 68 subjects participated in the study. On July 2017, top line data was received which was determined to be inconclusive. Due to poor data collection and higher-priority clinical programs, we decided not to pursue this indication. At present, we believe that it is unlikely that we will revive another study in Acne Vulgaris.

Renal tissue samples were obtained from the Department of Pathology. This research was approved by the Medical and Ethical Committees of Southwest Hospital, The Third Military Medical University. All human experiments were performed in accordance with the guidelines of The Third Military Medical University.

Consists of (i) 3,420,822 ordinary shares, of which 3,416,822 are held through G. Yarom Medical Research Ltd., a company incorporated under the laws of the State of Israel, of which Mr. Baharaff is the controlling shareholder and the chairman of its board of directors and 4,000 ordinary shares held by Mr. Baharaff, which were purchased in the open market; and (ii) options to purchase 654,645 ordinary shares that are currently exercisable within 60 days as of February 28, 2019. Of the 4,075,467 ordinary shares, Mr. Baharaff exercises sole voting and dispositive power over 658,645 shares beneficially owned and shared voting and dispositive power with G. Yarom Medical Research Ltd. over 3,416,822 shares.

In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for non-employee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. The Company elected to early adopt these amendments on June 1, 2018. The adoption of these amendments did not have a significant impact on our consolidated financial statements and related disclosures.

Curran, J. M. et al. The osteogenic response of mesenchymal stem cells to an injectable PLGA bone regeneration system. Biomaterials 34, 9352–9364 (2013).

(A) RNA was isolated in kidneys from P311+/+ (n = 6) and P311−/− (n = 6) mice after UUO or sham operation. α-SMA mRNA expression was determined by real-time PCR. (B) Representative photomicrographs of α-SMA-specific immunohistochemical staining of the obstructed kidneys from both P311+/+ and P311−/− mice on day 7. Black arrowhead indicates the α-SMA-positive region. Bottom panel: negative controls for the immunohistochemical staining of α-SMA on the obstructed kidneys from both P311+/+ and P311−/− mice. (C) α-SMA-positive region was quantified in stained sections from P311+/+ (n = 6) and P311−/− (n = 6) mice 7 days after UUO. (D) Western blot analysis of α-SMA protein levels. α-SMA protein levels in each treatment group (n = 3 per group) were quantified. A-D are representative of at least three similar experiments. Scale bar: 100μm. Data are presented as the mean ± SD. *P < 0.05; **P < 0.01.