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(A) Representative F480-stained sections of UUO kidneys from P311+/+ (n = 6) and P311−/− (n = 6) mice. Black arrowhead indicates the F480-positive cells. Bottom panel: negative controls for the immunohistochemical staining of F480 on the obstructed kidneys from both P311+/+ and P311−/− mice. (B) The graph represents the total number of F480-positive sections from five contiguous high-powered fields per kidney section. (A) and (B) are representative of at least three similar experiments. Scale bar: 100 μm. Data are presented as the mean ± SD. *P < 0.05; **P < 0.01.

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Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases.

        A patent claiming a new drug product may be eligible for a limited patent term extension under the Hatch-Waxman Amendments, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review. The restoration period granted is typically one-half the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the ultimate approval date. Patent term

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        The Company is contingently liable under an unused letter of credit with a bank, related to the Company’s facility leases. Refer to Note 6, "Commitments and Contingencies." As a result, as of December 31, 2018 and 2017, the Company had restricted cash as presented in the table below, securing the letters of credit. The cash will be restricted until the termination or modification of the lease arrangement.

Patients in the ARREST study were planned to undergo MRS, and a liver biopsy at baseline and week 52, which were centrally read, blinded to treatment allocation. The statistical analysis plan included pre-defined analysis sets: (i) a full analysis set for MRI (FAS – MRI): all intent to treat, or ITT, patients with baseline and at least one second MRS. 214 patients were included in this analysis set (41 in placebo; 90 in Aramchol 400mg; and 83 in Aramchol 600mg); and (ii) a full analysis set for liver biopsy (FAS – biopsy): all ITT patients with baseline and a second biopsy. 198 patients were included in this analysis set (40 in placebo; 80 in Aramchol 400mg; and 78 in Aramchol 600mg).

I’ve read a couple of a papers that suggest you can improve on OSKM quite considerably by including some extra factors. According to this paper: ‘Two Supporting Factors Greatly Improve the Efficiency of Human iPSC Generation’, you can improve the efficiency of reprogramming by 100 times using either p53 siRNA or UTF1. Now I know you don’t want to go all the way back to pluripotency, but this might still be useful.

        Collaborations are complex and time-consuming to negotiate and document. Further, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Any collaboration agreements that we enter into in the future may contain restrictions on our ability to enter into potential collaborations or to otherwise develop specified product candidates. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

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We may be forced to abandon development of Aramchol, or any future product candidates, which would have a material adverse effect on our business and may force us to cease operations.

Auriga Laboratories, Inc. , (OTCPK:ARGA ) Auriga Laboratories is a specialty pharmaceutical company building an extensive product portfolio of prescription brands targeting high growth therapeutic categories in the respiratory, dermatology, and psychiatry markets.

of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. We would cease to be an emerging growth company on the date that is the earliest of: (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) December 31, 2021; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

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).


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