FDA is notoriously stringent in approving medical applications. Some countries will accept FDA-approved products on their own markets with only a primarily administrative application process. In other regions (e.g. CE Mark in Europe and TGA in Australia) you can use the same clinical trial results and other evidence that was used for FDA approval. The money being spent on FDA approval will pay dividends in most other places, as long as they get it.
Doing things this way increases the short term cash burn but allows stronger once the pieces are in place.
My big concern... and from my perspective, it's big... if rollout takes so long and so much human resource, how is the company going capitalise on that growth potential?! If they get FDA approval and 1,000 facilities all sign orders in USA, what are they going to do with all those other countries standing in line waiting for years?
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