There seems to be a consistent pattern here with both cancer and aging – that a therapeutic is making the cells respond in a certain way, which makes them resistant to the changes induced by aging or cancer. That this mechanisms would be via epigenetics makes total sense.

The route of administration, formulation or dose for zilucoplan, which we are currently developing for SC self-administration, may be inadequate.

Products eligible for patent term extension (PTE) include human drugs[i], human biological products such as viruses, therapeutic sera, toxins, antitoxins, vaccines, blood/blood components or derivatives, allergenic products, or analogous products[ii], animal drugs and veterinary biologics, medical devices, and food or color additives subject to regulation under the Federal Food, Drug, and Cosmetic Act (FFDCA).[iii]

Yohai Stenzler, our Chief Financial Officer, has served in such capacity since February 1, 2017. Mr. Stenzler joined the Company in June 2014 as the Company’s corporate controller, and later on served as the Company’s Director of Finance. Mr. Stenzler has six years of financial management experience as an accountant at the real estate department at Ernst & Young LLP, where he was involved in financing, taxes, auditing, advising and accounting of public and private companies, both domestic and international. Mr. Stenzler is a certified CPA and holds a MBA in Finance from Recanati Business School at Tel Aviv University, and a BA in Economics and Accounting from Ben-Gurion University of the Negev.

In this case, the valsartan recall was originally traced back to a problem with the material from Zhejiang Huahai Pharmaceuticals. That’s the Chinese manufacturer who made the API itself. There were originally two generic companies whose tablets included the ZHP material, Teva and Prinston. But the Teva material was sold by Major Pharmaceuticals and also by Actavis, while the Prinston was sold by Solco Healthcare – there are those three layers of API production, pill manufacturing, and repackaging. It turned out that there were nine more repackagers of the Teva and Prinston tablets, so valsartan packages under those other names were added to the recall list. But not all of them. To add the confusion, some of the packages from those companies were still OK, because they’d bought the tablets from more than one manufacturer. The recall had to be done by batch number. Meanwhile, Torrent Pharmaceuticals also emerged as a company who had bought the original valsartan API from Zhejiang Huahai, so their products went on the list as well.

Examples of other PLG microparticles on the market include Risperdal Consta (risperidone for antipsychotic indications), Vivitrol (naltrexone for alcohol addiction), and Bydureon (GLP1 peptide to treat type 2 diabetes).

The Companies Law allows us to create and issue shares having rights different from those attached to our ordinary shares, including shares providing certain preferred rights, distributions or other matters and shares having preemptive rights. As of the date hereof, no preferred shares are authorized under our Articles. In the future, if we do authorize, create and issue a specific class of preferred shares, such class of shares, depending on the specific rights that may be attached to it, may have the ability to frustrate or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium over the market value of their ordinary shares. The authorization and designation of a class of preferred shares will require an amendment to our Articles, which requires the affirmative vote of at least 75% of the voting rights of the Company represented personally or by proxy and voting thereon at a general meeting at which a quorum is present. The convening of the general meeting, the shareholders entitled to participate and the majority vote required to be obtained at such a meeting will be subject to the requirements set forth in the Articles and the Companies Law as described above in “— Shareholder Meetings.”

Rashid, S. et al. Decreased plasma cholesterol and hypersensitivity to statins in mice lacking Pcsk9. Proceedings of the National Academy of Sciences of the United States of America 102, 5374–5379, doi: 10.1073/pnas.0501652102 (2005).

        The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our future development partners will be successful in protecting our product candidates by obtaining and defending patents. These risks and uncertainties include the following:

        (1)   The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

In the event of grantee’s termination prior to a vesting date by reason of such grantee’s death or disability, all of such grantee’s RSUs shall immediately become vested as of the date of such termination. In the event of a grantee’s termination for cause prior to settlement, all of such grantee’s RSUs shall immediately be forfeited for no consideration as of the date of such termination. If a grantee’s employment or service is terminated for any other reason, (1) all vesting with respect to such grantee’s RSUs shall cease, (2) all of such grantee’s unvested RSUs shall immediately be forfeited for no consideration as of the date of such termination, and (3) to the extent not already settled, all of such grantee’s vested RSUs shall be settled in accordance with the settlement schedule set forth in the applicable award agreement.

According to EMA, the presence of the NDMA, which is a probable human carcinogen, is thought to be related to a change in manufacturing processes. The agency’s Committee for Medicinal Products for Human Use (CHMP), is reviewing the possible impact of NDMA on patients and what steps can be taken to eliminate the impurity from future batches of product.