August 14, 2013
Nuvilex May Opt For Future Clinical Trials Abroad
Given the substantial costs to administer and conduct clinical trials exclusively in the U.S., it is likely that Nuvilex, Inc. (OTCQB – NVLX- $0.165 – Spec Buy) will elect to turn to overseas locations for future clinical trials. This strategy is neither novel nor an issue for regulators such as the U.S. Food and Drug Administration (FDA). Moreover, it makes perfect sense for an emerging biotechnology firm such as Nuvilex.
According to published reports, in 2008, roughly 6,500 clinical trials were being conducted in foreign countries of drugs intended for American use. In the same year, the inspector general of the Department of Health and Human Services compiled a comprehensive study that demonstrated roughly 80% of the drug applications submitted to the FDA for new drugs contained data generated from clinical trials conducted in foreign lands. Given these facts, in some cases, companies are conducting all of their clinical testing abroad. In fact, the inspector general’s report noted that the 20 largest U.S.-based pharmaceutical companies administered or conducted approximately one-third of their clinical trials at foreign sites.
It is easy to see why companies are flocking abroad, followed by some of the leading contract research organizations (a.k.a. clinical research organizations or CROs) which generate billions in annual revenue by operating globally on behalf of U.S.-based pharmaceutical and biotech companies. While the primary reason for a company such as Nuvilex to elect to conduct clinical trials abroad is a reduction in overall operating costs (which could be 20% or more lower than in the U.S.), other considerations can include easier or faster patient enrollment. For example, there are some nations ravaged by certain diseases more than others, or nations whose populace may carry disease-specific genetic markers at a higher rate than others.
Given the success of the predecessor firm that previously owned exclusive rights to the live-cell encapsulation platform to treat pancreatic cancer in Europe, it is possible that Nuvilex management elects to strike gold twice. Or, the Company could elect to conduct trials in Asia and other countries outside the U.S. where cost and enrollment favor the Company. In either event, Nuvilex is clearly working on what is best for the Company and its shareholders with respect to the protocols and sites for advanced clinical trials, and will consult with the FDA and drug regulatory agencies in other countries prior to finalizing its decisions. After all, once a company files a New Drug Application (NDA) with the FDA, complete study reports of the Phase II and Phase III trials that support the NDA must be submitted to that agency.
As Nuvilex management concludes all of the steps along the path to engaging in advanced clinical trials, and keeps investors apprised of its progress, shareholders will certainly be rewarded as these milestones are achieved.
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Senior Analyst: Robert Goldman
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