Great work ravens - thank you very much.
I focused on one particular paragraph which may just pry the door of approval for BIEL and similar companies a bit more. Don't want to hype a thing here, just simple common sense works best for me.
Quote:
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology. Unquote
Seems to me that BIEL slides right in here on several counts:
1. It is low-risk;
2. Serious conditions, whose medical needs are unmet by current technology. No question in my mind that chronic pain is a serious condition here in the US. It is costing us many Billions of dollars every year in lost time, lost earnings and lost productivity. And we are drugging the "serious conditions with harmful chemicals that often exacerbate the issues;
3. Great to see the feds and the FDA shining intelligent and proactive lights on the issues surrounding Rx and non-RX drugs;
4. How many Americans, male and female and of all ages, suffer from chronic pain every day of their lives?;
5. Among those, how many are women who suffer from chronic cramping and pain from menstrual issues, month after month, year after year from high school to senior years, only to drug themselves, sometimes senseless, to carry on functioning at work or in their critical role running families and homes? Awful how we can maintain ways of hurting ourselves when there are options available; and
6. Best parts? Drug-free, side-effect free and patented! Let's go folks, cautiously, prudently, yes, but time's a wasting. There is nothing I can see but upside, for Americans suffering pain of allsorts, both temporary and chronic and the company and its shareholders. The American way, but we are late since many very civilized countries, like Canada and the UK already have BIEL approved for OTC sales. We're a little behind, but we're coming like a train with this one.
Thanks again ravens
