Drug Efficacy ConcernsThe FDA's concerns about the lack of substantial evidence of a clinically meaningful benefit of roluperidone may lead to skepticism regarding its potential market success.
Financial ConstraintsMinerva's financial constraints could be exacerbated by the need to fund further studies for roluperidone, impacting the company's cash flow and investor confidence.
Regulatory ChallengesThe FDA's requirement for Minerva to conduct additional studies to demonstrate the safety and effectiveness of roluperidone casts doubt on the drug's approval timeline.