The FDA didn't request the meeting. BIEL did.
You all know that, right? It's ALWAYS the company requesting the meeting with the FDA, and usually because the FDA told the company something they didn't like, causing the company to request a meeting for clarification.
Pretty clear to me: The FDA told BIEL "We have questions, and the pathway is de novo," and BIEL asked for the meeting.
In June and again in July.
When will BIEL tell you that the 510(k) is dead and it's going to be a de novo now? Probably in September when they have the Oxford data.
Meanwhile, Q2 financials will be out in four weeks. Better get some excuses ready. The excuses from the past three quarters are wearing thin.