FDA confirms requirement for confirmatory study of roluperidone for the treatment of negative symptoms in schizophrenia
Related Questions
How does the requirement for a confirmatory study compare to regulatory expectations for similar antipsychotic programs at peer companies?
How will the FDA's requirement for a confirmatory study of roluperidone affect Minerva Neurosciences' projected timeline and cash burn?
What is the market's expected reaction to the secondâquarter financial results in light of the FDA update?
Will the need for additional clinical data dilute the potential upside of roluperidone and impact the valuation of MNVA?
What are the potential implications for future partnership or licensing opportunities if the confirmatory study delays roluperidone's launch?
How might the earnings release and FDA news influence shortâterm trading volume and volatility for MNVA?
What is the expected cost and timeline of the confirmatory trial, and how will it affect the company's runway and need for equity financing?
Are there any contingency plans or alternative asset programs that Minerva could prioritize if roluperidone faces further regulatory hurdles?
How does the current cash position and Q2 results support the additional R&D spend required for the confirmatory study?
What impact could the FDA requirement have on the projected market size and revenue potential for roluperidone in treating negative symptoms of schizophrenia?