Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure. 

Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.

Aspirin: It seems that a low dose of Aspirin in the range of 50 – 81 mg or even as low as 30 mg has the same anti-blodd-clotting effects as a normal to high dose of 300 – 1200 mg. 1) https://books.google.de/books?id=GnIQGmiSylkC&pg=PA1108&lpg=PA1108&dq=aspirin+75mg&source=bl&ots=iXpVbhuZQ7&sig=m1sJvOT_tDJzHXcony2F9MATen0&hl=de&sa=X&ved=0ahUKEwi01cuq_bDQAhVKDsAKHRMOAYY4ChDoAQhzMAM#v=onepage&q=aspirin%2075mg&f=false 2) https://www.ncbi.nlm.nih.gov/pubmed/4082090 3) https://www.ncbi.nlm.nih.gov/pubmed/10870801

We maintain one equity-based incentive plan, our 2013 Incentive Share Option Plan, or the 2013 Plan. As of February 28, 2019, the latest practicable date for inclusion in this annual report, a total of 4 shares were reserved for issuance under our 2013 Plan, of which (1) options to purchase 2,349,054 ordinary shares and 13,869 restricted stock units, or RSUs, were issued and outstanding thereunder (i.e., were granted but not canceled, expired or exercised); (2) options to purchase 1,147,988 ordinary shares were exercised and 41,462 ordinary shares were issued upon vesting of RSUs, and (3) 784,047 shares remain unallocated for future equity awards pursuant to our 2013 Plan. 

        Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If any future collaborator of ours is involved in a business combination, it could decide to delay, diminish or terminate the development or commercialization of any product candidate licensed to it by us.

        We are developing specific inhibitors of Factor D, a critical component of the alternative pathway of complement, as targeted drug candidates for C3GN. By blocking the alternative pathway upstream of C3, we believe that this mechanism may prevent C3 deposition and subsequent renal injury.

Certain distributions treated as dividends that are received by an individual U.S. Holder from a “qualified foreign corporation” may be classified as “qualified dividend income,” — which is generally taxed at the lower applicable long term capital gains rates provided certain holding period and other requirements are satisfied. A non-U.S. corporation (other than a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange of information program, or (ii) with respect to any dividend it pays on stock which is readily tradable on an established securities market in the United States. As discussed below under “Passive Foreign Investment Company,” we believe that we were not a PFIC for our 2018 taxable year. However, we do expect to be a PFIC for the 2019 taxable year. Because the PFIC determination is highly fact intensive, there can be no assurance that we will be a PFIC in 2019 or for any other taxable year. Our ordinary shares will generally be considered to be readily tradable on an established securities market in the United States if they are listed on the Nasdaq Capital Market, as we intend our ordinary shares will be. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for dividends paid with respect to our ordinary shares.

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Galougahi, K. K. et al. Glutathionylation mediates angiotensin II-induced eNOS uncoupling, amplifying NADPH oxidase-dependent endothelial dysfunction. J Am Heart Assoc. 3, e731 (2014).

However, unless you know what too look for, you won’t find it. The impurities in question were also occurring at very low levels, so the product could still be 99.999% pure. It’s the 0.001% that’s the problem.

Market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Yeagle, P. L. The biophysics and cell biology of cholesterol: An hypothesis for the essential role of cholesterol in mammalian cells. in Cholesterol in Membrane Models (ed. Finegold, L. ) 1–10 (CRC Press, Boca Raton, 1993).