NO! They claim they need another $50M to commercialization, not merely to FDA approval. This includes building early production units, development and roll-out of distribution and service organizations (North American and European, possibly requiring separate organizations), getting the training program into higher gear for imminent sales volumes... Commercialization goes well beyond FDA approval.
If Mr. McNally was intentionally blowing smoke up everyone's backsides about the amount of money required, he could just as well have said the existing $30M will get us there, or maybe another $15M or $20M. He has been through this process repeatedly before, and always successfully. He knows what it takes to get there, and the $50M estimate should be fairly reasonable. If there was any gamesmanship going on in these estimates, it probably is a safety factor already built into the numbers - he has shown us that he isn't afraid to present bad news when it's the reality (e.g. schedule). But I don't think he is padding the numbers beyond any reasonable buffer for minor adjustments to the plan.
And I will add that in his 30 years of medical device experience, he has had only success. His prior career experiences included development engineering, sales, marketing, and management. It is not a trivial undertaking. He knows every aspect of what it takes to get a successful product to market, and has done so every time he has tried.
