BALTIMORE, MD--(Marketwired - Aug 21, 2013) - In a newly released research update, Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes that a relatively new FDA program benefits Nuvilex, Inc.'s (
While a great deal of attention has been paid to Nuvilex's technology, efficacy, and past clinical trial results that key changes within the Food and Drug Administration (FDA) seem to have gone unnoticed.
The FDA has 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 with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
The FDA's oncology chief noted in a recent conference 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 2 expedited programs, fast track and breakthrough. 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."
Moreover, the guidelines noted that data is preferred to be derived from Phase I and Phase II clinical trials. Given the very favorable Phase II results from Nuvilex's previous trials, if Nuvilex were to receive this designation it may materially reduce development time which would save time and money, thus strongly benefitting shareholders. It should also be noted that any Firm awarded an expedited 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.
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About Nuvilex, Inc. (