Kristen Kluska, an analyst at Cantor (Overweight), said the Food and Drug Administration's (FDA) "briefing document paints a bad picture." She stressed that the documents "raised multiple concerns and raised allegations about the integrity of
Kristen Kluska, an analyst at Cantor (Overweight), said the Food and Drug Administration's (FDA) "briefing document paints a bad picture." She stressed that the documents "raised multiple concerns and raised allegations about the integrity of the data collection". She believes the problem stems from "a difference in how the data was analyzed: the FDA used a four-year-old version in its analysis, while Capricor used a newer, updated version." She noted that Capricor management believes the statistical scheme used by the FDA is not applicable to this data set and plans to demonstrate "overall clinical significance across skeletal and cardiac endpoints." Capricor management told Kluska that "the PUL 2.0 metric achieved statistical significance in every statistical version they have, except the version used by the FDA in this briefing document."