513(g) and/or 510(k)
Is the company seeking 513(g) or 510(k) approval, or both (or am I not understanding what is going on) (or is the company mis-reporting?)
FDA - our 513(g) Pre-submission was achieved November 7, 2017. We are scheduled to meet with the FDA on January 18, 2018; in advance of the meeting, we will receive feedback from the FDA relative to our pre-submission document …
" The purpose of our 513(g) pre-submission and subsequent FDA interaction is to clarify the specific regulatory pathway in order to achieve the necessary FDA approval in order for us to fully commercialize AsepticSure® to the hospital/healthcare market in the U.S. …
Now, with these recent accomplishments, as well as our proceeding with the FDA 510(k) discussions, our outlook is improved and opportunities are available. …
Overall, we need a minimum capital raise of approximately $5 million, which will enable us to ensure that we are operating our business successfully, focused on growth in value, while addressing various longer-term, existing accounts payables. Currently, I and others in management, the board of directors and, various consultants are deferring all salary payments and work-related expenses. We are focused on what we consider are most critical to support our regulatory efforts [i.e., FDA 510(k) and various country-specific requirements], maintaining compliance with all financial regulatory reporting requirements, working to establish a commercialization basis for AsepticSure® and, securing additional capital to support the business. …
Over the near-term, we expect to report on the upcoming FDA meeting, addressing the 510(k) approval-path for AsepticSure®. In addition, we hope to report additional participation in the current private placement offering. There are also various business building activities underway that may solidify, providing us with additional encouraging news to report.
