Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

In a Nov. 29, 2018 warning letter to Zhejiang Huahai Pharmaceutical (ZHP), FDA noted that the agency “has grave concerns about the potential presence of mutagenic impurities in all intermediates and API manufactured at your facility, both because of the data indicating the presence of impurities in API manufactured by multiple processes, and because of the significant inadequacies in your investigation.”

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for testing for the impurities in August and September (8,9). FDA and EMA also found cGMP deficiencies at the company’s facility. FDA placed the company’s products under Import Alert on September 28 (10), when EMA also revoked its right to sell the product in Europe (11). In an FDA 483 published on September 21, based on inspections in July and August (12), FDA found fault with the company’s change-control system and its “failure to evaluate all potential risks from the 2011 manufacturing process change.” The company had hired an outside lab to conduct a small-scale research project assessment without pilot-scale testing or a formal risk assessment, the inspectors wrote. In addition, the 483 found that the company did not have a quality agreement in place with that outside lab. Inspectors also found fault with Zhejiang Huahai’s inconsistent classification of risks in different process change documents. Where the initial change request classified the process change as critical, DMF amendments sent in 2013 classified the changes as minor, inspectors wrote. Among other problems, FDA inspectors also singled out inadequate validation, cleaning procedures, analytical methods, sampling and testing, and equipment maintenance: However, observers see some of

Kokkiripati, P. K. et al. Gum resin of Boswellia serrata inhibited human monocytic (THP-1) cell activation and platelet aggregation. J Ethnopharmacol. 137, 893–901 (2011).

        We also own three U.S. patents, and have received a notice of allowance in a fourth application in another patent family. Along with this family we are prosecuting various patent applications directed to other technologies. The U.S. patents are expected to expire in 2034, and any patents granted on the pending applications are expected to expire between 2034 and 2038, subject to possible patent term extensions.

        Our management has broad discretion to use our cash and cash equivalents to fund our operations and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of our product candidates. Pending our use to fund operations, we may invest our cash and cash equivalents in in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return.

        Research and development expenses consist primarily of costs incurred for our research activities, including development of our proprietary chemistry technology platform, and our pre-clinical and clinical candidates, which include:

        We have never declared nor paid cash dividends on our capital stock. We currently plan to retain all of our future earnings, if any, to finance the operation, development and growth of our business. In addition, the terms of any future debt or credit agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

Liu, L. et al. Heat shock protein 27 regulates oxidative stress-induced apoptosis in cardiomyocytes: mechanisms via reactive oxygen species generation and Akt activation. Chin. Med. J. 120, 2271–2277 (2007).

To me, the 2012 Blasco study looks very interesting. However, I am not familiar with gene therapy so I am more in a learning mode here. Of particular interest, multiple measures of aging improved in the 2 mTERT groups compare to the other groups (control and eGFP group): decreased p16 levels, decreased short telomeres, increased bone density, decreased insulin levels,…). Life span increase was significant in both 1y and 2y groups.

I do not eat flesh foods, and have not since age 16, after seeing a documentary on how they slaughter animals, so that may help keep IGF-1 lower.