The Company also holds a wholly-owned subsidiary, Galmed Research and Development Ltd., which was incorporated in Israel.
Brock, M. et al. Interleukin-6 modulates the expression of the bone morphogenic protein receptor type II through a novel STAT3-microRNA cluster 17/92 pathway. Circ. Res. 104, 1184–1191 (2009).
For discussions relating to certain compensation-related requirements of the Companies Law, external directors and financial experts, committees of the Board, and exculpation and indemnification of directors and officers, see “Item 6 – Directors, Senior Management and Employees.”
Changes in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary changes to clinical trial protocols, which could result in increased costs to us, delay our development timeline or reduce the likelihood of successful completion of our clinical trials.
Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting adverse reaction, documented enhancement of patient compliance that is expected to lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.
Böger, R. H., Maas, R., Schulze, F. & Schwedhelm, E. Asymmetric dimethylarginine (ADMA) as a prospective marker of cardiovascular disease and mortality—an update on patient populations with a wide range of cardiovascular risk. Pharmacological Research 60, 481–487 (2009).
Harzheim, D. et al. Cardiac pacemaker function of HCN4 channels in mice is confined to embryonic development and requires cyclic AMP. EMBO J 27, 692–703 (2008).
Any consideration related to the sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the licenses granted to Merck and therefore were excluded from the transaction price.
Cells grown in six-well slide chambers, after two washes with PBS, cells were fixed in 100% ethanol for 30 min. After 30 min of blocking of nonspecific binding with PBS containing 3% BSA, cells were incubated for 2 h at room temperature with a 1:100 dilution of the anti-eNOS (phospho Ser1177) antibody. After accurate washings, cells were further incubated for 1 h at room temperature with goat anti-rabbit IgG conjugated to Dylight 549 (diluted 1:100). After washing with PBS, Nuclei were incubated for 2 min at room temperature with DAPI (5 μg/ml). At the end, cells were washing twice with PBS, and cells were mounted in aqueous mounting medium and covered with coverslips. Specimens were evaluated with a microscope, and the images were captured using a Spot charge coupled device camera system.
Abviva, Inc ( OTCPK:ABVV) was established to develop and commercialize diagnostic and therapeutic products from a novel breast cancer growth inhibitory protein. Research scientists at the prestigious University of Michigan Cancer Center discovered a secreted protein produced in normal breast epithelial cells that inhibits the growth of breast cancer. This discovery was developed into a diagnostic blood test for breast cancer, Mammastatin Serum Assay (MSA). The MSA will be used to screen women for early detection of breast cancer. In clinical studies Mammastatin was found to be normally present in blood serum of healthy women and absent in women with breast cancer. Abviva intends to offer the MSA to women and their doctors through its wholly owned clinical reference laboratory, Biomedical Diagnostics, LLC.
M.M.W., Y.W.L. and A.D.W. conceived and designed the experiments. M.C.C., Y.D. and Z.H.Z. performed the experiments. Y.K.Z. and P.F.W. analyzed the data. J.W.W. and Y.Q. contributed reagents/materials/analysis tools. M.M.W. and L.L. wrote the paper. All authors reviewed and approved the final manuscript.
Our industry has experienced a high rate of turnover of management personnel in recent years. Any of our personnel may terminate their employment at will. If we lose one or more of our executive officers or other key employees, our ability to implement our business strategy successfully could be seriously harmed. Furthermore, replacing executive officers or other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain marketing approval of and commercialize products successfully.
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