August 21, 2013
New FDA Program Benefits Nuvilex
When events in progress take longer to complete than originally expected, investors often forget that upcoming events may be as important as or even more critical than previous milestones. For longtime investors in Nuvilex, Inc. (OTCQB – NVLX - $0.15 – Spec Buy), so much attention was paid to technology, efficacy, and past clinical trial results that key changes within the Federal Drug Administration (FDA) seem to have gone unnoticed.
To enable its ongoing efforts to bring innovative drug products to the public as efficiently as possible, the FDA relies heavily on a number of expedited development and review tools. Interestingly, the FDA launched a new tool known as the “breakthrough therapy” designation. This new designation is now helping the FDA assist drug developers expedite the development of new drugs or therapies with preliminary clinical evidence that indicates the drug or therapy may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
To underscore the potentially beneficial nature of this program in the oncology space, the FDA’s oncology chief spoke at the June ASCO (American Society of Clinical Oncology) meeting about how the designation is now being used to shorten development time for some firms.
The bottom line is that the oncology chief suggested that any drug development team working on a breakthrough drug will have no trouble getting steady feedback from the agency, and in particular the oncology division he runs. This is especially the case where the division and the agency view these drugs as potentially "transformative" therapies capable of changing the course of patients' lives. Any drug granted this designation would actually receive priority over those drugs designated as fast track.
This is an important development for Nuvilex as the Company now has the opportunity to submit the qualifying documents for two expedited FDA-approval programs; namely “fast track” and “breakthrough therapy.” While there are no assurances that the Company would be granted either of these designations, we believe that the odds may ultimately favor Nuvilex in this instance. According to FDA guidelines, one of the key qualifying criteria is determining factors is that: “a drug must be intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.” A drug or therapy that is granted the “breakthrough therapy” designation is also eligible for all of the benefits of “fast track” status.
Moreover, the guidelines noted that data is preferred to be derived from early and/or mid-phase clinical trials for a drug or therapy to be considered for these designations. Given the very favorable Phase II results from Nuvilex’s previous trials, if Nuvilex were to receive one or both of the designations, overall development/approval time would be materially reduced, which would save time and money, thus strongly benefitting shareholders. It should also be noted that any Firm awarded an expedited review designation for a drug is typically afforded a higher valuation as the Street believes it is an indication that the FDA may be favorably disposed toward the drug, even at an early stage.
For more information, refer to our previous NVLX Reports, Updates and Hot Topics by visiting www.GoldmanResearch.com
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Senior Analyst: Robert Goldman
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