Applied Visual Sciences, Inc. (OTCBB:APVS ) is the holding company and IT development organization for subsidiaries specializing in high-performance imaging analysis technologies and advanced analytics for automated recognition of targets of interest. Applied Visual Sciences’ subsidiaries include Guardian Technologies International , Inc., a homeland security/defense technology entity, and Signature Mapping Medical Sciences, Inc. , a healthcare technology entity. The company is quoted on the OTC Bulletin Board under the symbol APVS.

We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.

        In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the statute. To obtain approval of a generic drug, an applicant must submit an abbreviated new drug application, or ANDA, to the agency. In support of such applications, a generic manufacturer may rely on the pre-clinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug, or RLD.

I agree that we were just speculating. On my side, it is based on nothing. It is not science at all (again on my side). Just having fun. Maybe we should not do that here. I’ll try to be more careful.

The requirements that we and our collaborators must satisfy to obtain regulatory approval by government agencies in other countries prior to commercialization of Aramchol or any future product candidates in such countries can be rigorous, costly and uncertain. In the European countries, Canada and Australia, regulatory requirements and approval processes are similar in principle to those in the United States. Additionally, depending on the type of drug for which approval is sought, there are currently two potential tracks for marketing approval in the European countries: mutual recognition and the centralized procedure. These review mechanisms may ultimately lead to approval in all EU countries, but each method grants all participating countries some decision-making authority in product approval. Foreign governments also have stringent post-approval requirements including those relating to manufacture, labeling, reporting, record keeping and marketing. Failure to substantially comply with these on-going requirements could lead to government action against the product, us and/or our representatives.

        If U.K. leaves the E.U. it will no longer fall under the regulatory jurisdiction of EMA. Additional regulatory filings to the MHRA would be needed in the U.K. to secure approval to market zilucoplan in that country. There are risks that requirements for registration in the U.K. may be different than those established by EMA.

Smith, B. C., Underbakke, E. S., Kulp, D. W., Schief, W. R. & Marletta, M. A. Nitric oxide synthase domain interfaces regulate electron transfer and calmodulin activation. P. Natl. Acad. Sci. 110, E3577–E3586 (2013).

Tellez, J. O. et al. Differential expression of ion channel transcripts in atrial muscle and sinoatrial node in rabbit. Circ Res 99, 1384–93 (2006).

AmpliPhi Biosciences (OTC:APHB ) is a biotechnology company dedicated to the development of innovative antibacterial solutions to improve human and animal health through the application of its proprietary bacteriophage platform. The Company’s lead product development programs are targeting Gram-negative infections that are often resistant to existing antibiotic treatments.

Tran, C. T., Leiper, J. M. & Vallance, P. The DDAH/ADMA/NOS pathway. Atherosclerosis. Supplements 4, 33–40 (2003).

        At the signing of the Merck Agreement, Merck paid an upfront nonrefundable, technology license fee of $4.5 million. In addition, the Merck Agreement provides for reimbursement of research and development services provided by the Company and includes low to mid-single digit percentage royalties on future sales, if any, and milestone payments that could total up to $65.0 million, including pre-clinical and clinical milestones of $20.0 million, $6.0 million of which have been received to date, regulatory milestones of $19.0 million, and commercial milestones of $26.0 million.

Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.