I suppose that's relevant if you're a trader. Those are the...

I suppose that's relevant if you're a trader. Those are the sorts of things that can influence the short term price movements.

If you're an investor, I believe the long term share price and the value of the company will be dictated by the success of the product.

That's why I think it was worth asking questions around the rigourous-ness of the FDA clearance process. And to be honest I'm still left with questions after a few hours of research. Such as, what is the absolute effectiveness standard required to obtain FDA clearance? I note the FDA evaluates effectiveness before granting clearance through the 510k process - but does so on the basis that it's as effective as a similar device. If the comparison device is only so-so effective, could you still pass the effectiveness requirement quite easily, without your device being very effective? Is that a possible scenario?

Anyway, I think there's probably a lot more to research here to get a truly informed picture. More than I can justify spending time on as someone who's merely curious about the stock, and not a holder. Maybe these are some avenues serious LDX holders can investigate.