I suspect the market sees FDA Clearance as binary outcome, which it isn't. Not in terms of whether or not they get Clearance, or what it means for the company's future.
I held Factor Therapeutics, FTT, formerly ReCell. That was a binary outcome. Anyone involved in that debacle will know what I'm talking about, with the SP effectively going to zero the split-second the announcement was released. Painful lesson.
CardieX's future does not hang on Clearance. Nothing is a given, but the ongoing dialogue between CDX and the FDA advisor who they have dealt with before suggests everything is on track for the desired outcome. Even if they do 'only'' get an interim Rx clearance and have to go back for OTC, it isn't the end of the world. They will still have the only medically certified FDA Cleared CBP/cardiovascular health monitoring device in the world. What that will mean for revenues in the all-important clinical trials/medical professional clinician market should not be underestimated. OTC is just one opportunity of many.
Nobody is really talking about IP licensing opportunities outside the traditional medical/pharma markets.
I've got a feeling there's more going on than we know about.
Of course, that doesn't mean squat the way things stand. The market is fixated on FDA and there isn't anything we can do about it except wait.
