CUV is not all about SCENESSE, but until July 8, when the result of the FDA's decision is annouced, it might as well be.

The Chairman released a letter recently - it's hard to draw any information about likelihood from this. They are "literally around the clock" working to respond to FDA queries though. It also seems the focus of the questions is not on the drug itself but on the review aspects of treatment - something that should be in CUV's power to control.

Research shows upwards stock movement 60 days prior to FDA approval dates is correlated with a positive decision (https://www.ncbi.nlm.nih.gov/pubmed/21949081).

We also know drugs under priority review, like this one, are more likely to get approved than non priority review drugs. Also, rare diseases are more likely to get drug approval.

On the valuation, sure it may be stretched now, but it's likely to remain stretched until the July 8 decision at least. The odds of FDA approval are definitely greater than even, maybe 80%, therefore, this is a good long trade either on or up to (lower risk) the FDA annoucement.