Disagree. The update suggests to me the company is really working hard and making huge progress on getting the software to match the capabilities of the hardware device and at the same time is refining the usability of the hardware with new sheaths which are critical to both use and regulatory approval. AND has progressed the Denovo device submission and held another meeting recently with the FDA to which they can now supply a written clarification. All of this will likely pay a good commercial dividend once FDA approvals arrive and may even play a part in the nature of the approvals.
FDA approvals do take time. But the company isn't sitting on it's hands waiting for it to happen. And while they recorded a deficit due to the R&D costs, they also manage to double customer receipts.
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