my overall assessment as a long is basically OK but nothing earth shattering...
"basically OK" is OK by me, but I would rate it much higher. Look at it this way (from an investment perspective), if CLI get's "just" an "OK" from the FDA, the result is a multi-billion dollar market, a brand new disruptive (there's that word again) medical modality, and PSTI explodes upward. That's earth shattering! I do hope that the results are REALLY good (beyond the basic requirement for approval), because I hope that patients will get as much help as possible.
I think the FDA may find themselves in a conundrum when the CLI data is finalized... the p value may not be there signifying statistical significance
We'll have to see, but I'm very encouraged by the IC results and the fact that it confirmed their dosing strategy for CLI (that's what they said). Also, keep in mind how devastating that disease is (and how little toxicity), and that is part of the formula that will be used by the FDA. I'm optimistic on the coming CLI results.