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"title": "Earnings call: G1 Therapeutics reports growth and optimistic outlook By Investing.com",
"description": "Earnings call: G1 Therapeutics reports growth and optimistic outlook",
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"snippet": "G1 Therapeutics (NASDAQ: ) has reported promising financial results in their first-quarter earnings call for 2024, with a 34% increase in net sales year-over-ye...",
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"highlight": "As a reminder, the hazard ratio for the pembrolizumab arm of KEYNOTE-355 and the intent-to-treat or <em>ITT</em> (NYSE: ) population was 0.89. And the FDA-approved PD-L1 positive population was 0.73. So a positive result in PRESERVE 2 would mark the biggest improvement in overall survival to date in first-line metastatic triple-negative breast cancer.",
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"highlight": "Regarding this trial, we recently received feedback from the FDA recommending that the final analysis should be conducted in the <em>ITT</em> population which includes the survival events from patients that were enrolled in the Ukraine, rather than the modified <em>ITT</em> population that would have excluded them.",
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"highlight": "Maybe can you just give us an idea of what proportion of patients were from Ukrainian sites, and whether the company was advocating kind of one way or the other to do the <em>ITT</em> or the mITT observations, were there any issues with getting patients drug or data quality or anything like that? Thanks.\n\nRaj Malik: Yes. Hey, Joe.",
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"highlight": "So, we had initially proposed the modified <em>ITT</em> population, which would have excluded these patients and obviously the events. From these patients, the agency recommended that we include the events from these patients. And so it was really the discussion back and forth on how to do that, because there are a variety of approaches to do that.",
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"title": "Ahead of ITT (ITT) Q1 Earnings: Get Ready With Wall Street Estimates for Key Metrics",
"description": "Beyond analysts' top -and-bottom-line estimates for ITT (ITT), evaluate projections for some of its key metrics to gain a better insight into how the business might have performed for the quarter ended March 2024.",
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