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GNVC > SEC Filings for GNVC > Form 8-K on 21-Oct-2013All Recent SEC Filings

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Form 8-K for GENVEC INC


21-Oct-2013

Other Events


Item 8.01 Other Events.

On October 13, 2013, an article entitled, "Gehör Verschaffen," was published in Frankfurter Allgemeine Sonntagszeitung, a publication based in Frankfurt, Germany, reporting information about our hearing loss program that is licensed to the Novartis Institute for Biomedical Research, a subsidiary of Novartis AG. The article quoted and otherwise referenced information provided by representatives of Novartis regarding the potential timing of regulatory filings and the commencement of clinical trials with the lead clinical candidate for this program. We did not contribute to the article. The article, nevertheless, contains certain information regarding the program that we had not previously provided to investors, because it had been speculative and, to the extent provided to us by Novartis, was provided to us confidentially. The purpose of this 8-K is to provide investors with information from the article that we believe could be material to investors, because of the importance of the hearing loss program to us. We further believe it is necessary to provide this information because the article is written in German and may not be generally available. Specifically, the article states that Novartis "hopes" that an investigational new drug application, or IND, with regard to the lead clinical candidate for the hearing loss program, may be filed "at the beginning of 2014." While this statement is generally consistent with our understanding, we also understand that this IND could be filed as early as the fourth quarter of 2013. We also understand that additional regulatory filings required for conducting gene therapy trials in the United States have already been made by Novartis. The article also states that, "Within a year [of the filing of the IND], the first clinical trials [with the lead clinical candidate] could begin." If the IND is filed on or before the end of the first quarter of 2014, and the IND is not rejected, then it is our understanding that a clinical trial with this product candidate could commence during the first half of 2014.

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