Well, with FDA being such a major hurdle, I won't be surprised if it gets delayed by a quarter or so. This happens to just about any other start up trying to get FDA approval. So for me, that won't be a big deal. It would only be a big deal if the FDA rejects the application as happened to another company that we know of. When dealing with FDA, one has no choice if they want one to do more trial or collect more data and so forth. The company can only do what is within their control.
Cheers.
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