I have a strong feeling that more delays are waiting in the wings. They may be able to meet their mid year goal for filing 501K this summer, but that doesn't mean approval will come quickly. I copied this from their "risks" section of their latest 10-Q
"We believe that the pathway to marketing approval in the U.S. for our lead product candidate for internal use will likely require the process of FDA Premarket Approval (“ PMA “) for the product, which is based on novel technologies and likely will be classified as a Class III medical device. This approval pathway can be lengthy and expensive, and is estimated to take from one to three years or longer from the time the PMA application is submitted to the FDA until approval is obtained, if approval can be obtained at all."
The PMA that they mention here is the 501k filing. So this means that the product may not even be ready to sell until 2020.
This ticker may ride down in the near term. It may get a boost with the announcement of milestones. And then it may ride down some more in anticipation of the next big announcement. We are in the middle of one waiting game, and there will be quite a few more before this product comes to market.
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