Saturday, October 27, 2018 10:15:49 AM
As I said before, I expect with 99% certainty that FDA clearance will take place on or before November 2nd. What happens if they don't and what to expect:
While November 2nd is the 90 day benchmark for FDA approval, the FDA can extend the 90 days to 100 days with no obligation to inform BIEL about it. If, however, the FDA reaches 100 days, November 16, and the Actipatch is not approved, then the FDA must issue a letter to BIEL explaining why they have not approved it yet. Thus, I expect Biel to inform shareholders the following week with that letter if we reach that point.
Be Faithful, we waited for a long time here for the BIG BANG. NOW THE BIG BANG event is closer than ever.
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