Financial ConstraintsWhile the data previously generated for PrimeC has been promising, the company still has capital constraints, including its 'baby shelf' limitations, which will make it difficult to raise sufficient capital to fully finance the Phase 3 trial.
Funding UncertaintyNeuroSense still has not signed a definitive agreement with the previously-undisclosed partner to fund PrimeC’s Phase 3 program and commercialization.
Regulatory ChallengesThe company received negative feedback from Health Canada regarding an accelerated approval pathway for PrimeC for treating ALS.