Allegations
(a) during its meetings with the FDA prior to the start of the Class Period,
Trevena had been advised that the FDA did not agree with certain aspects of the design of the Phase III clinical trial of Olinvo, including the proposed dosing, the proposed primary endpoint and the proposed non-inferiority margin for comparing morphine to Olinvo; (b) unless Trevena demonstrated that Olinvo was at least equally effective to morphine in treating post-operative pain in the Phase III clinical trial, the FDA would be unwilling to consider any secondary benefits Olinvo might confer in terms of reduced opioid-related adverse effects ("ORAEs"); (c) the FDA disagreed with how the safety data was being compiled in the Phase II clinical trial; (d) because the FDA did not agree with major tenants of the design of the Phase III clinical trial, it was highly unlikely that the FDA would find the data obtained from that clinical trial sufficient to support Trevena’s NDA; (e) because the Phase III clinical trial data being derived would not likely be deemed sufficient to support the NDA for Olinvo, the Company would not be able to market Olinvo as soon as it was leading the market to expect, if ever; and (f) as a result of the foregoing, the Company was not on track to achieve the commercial sales revenues from Olinvo as soon as Defendants had led the market to expect during the Class Period, if ever.