Statistically Significant Results

Statistically Significant Results. Shall mean the analysis of the results of the Phase III Clinical Trial as required by a Regulatory Authority to satisfy efficacy requirements; and in the case of the Product in the Field for the FDA shall mean the analysis of the results using all patients in the Phase III Clinical Trial, calculated by including and/or excluding the training patients, and by measuring the recurrence rate of disease six months after the resection procedure as a primary endpoint, all of which must yield... statistical significance by FDA standards. -4- EXECUTION COPY [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. View More