Financial PerformanceThe company reported revenues of $11.7M with a net loss of $0.85 per diluted share, beating consensus estimated revenues of $8.0M with a net loss of $1.08.
Regulatory EngagementThe zele update will now include feedback from multiple regulatory agencies, rather than solely on the feedback of the FDA.
Strategic DevelopmentsThe decision to seek regulatory feedback is seen as a positive indicator for the progress of the data.