According to the lawsuit, the Offering Documents contained false and/or misleading statements and/or failed to disclose that:
- in order for Neumora to justify conducting its Phase Three Program, Neumora was forced to amend BlackThorn’s original Phase Two Trial inclusion criteria to include a patient population with moderate to severe major depressive disorder (“MDD”) to show that Navacaprant offered a statistically significant improvement in treating MDD;
- and to that same end, Neumora also added a prespecified analysis to the Phase Two statistical analysis plan, focusing on patients suffering from moderate to severe MDD; and
- the Phase Two Trials lacked adequate data, particularly in regards to the patient population size and the ratio of male to female patients within the patient population, to be able to accurately predict the results of the KOASTAL-1 study.
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