Of the four potential outcomes (missed PDUFA, full approval, complete response letter, or extension of PDUFA) the firm thinks the most likely outcome is that the FDA will simply miss the PDUFA date. They commented, " We continue to think that Afresa would need an expert panel if the FDA were actually considering approval of the product. While MannKind has repeatedly suggested that there is no need for an FDA panel, we continue to expect the FDA to host a panel at least 60 days prior to approval. Longer-term, we do not think MannKind will be able to find a partner for Afresa and, if approved, we do not think the market will accept the product in a meaningful way."
So far, he's been right. It certainly leads me to believe the stock might open lower monday