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Monday, March 18, 2013 10:55:22 AM
Who in government or the FDA today would or could not see the advantages?
Women by the millions relieved of serious menstrual cramping costing the economy billions of dollars every year with ALLAY and a pain relieving, drug-free solution for minor injuries with ActiPatch? That's drug-free, with no negative side-effects, ever? It is total nonsense that BIEL's product line is not already approved for OTC sales, but the FDA apparently stated that it was hiring 200 people to deal with the emerging device market and related applications for regulatory approval. I have to say I did not see a press release to this effect myself, read about it here. I'm sure one of the other shareholders knows how to access that announcement. Many shareholders who know first-hand how well the products work are enraged at the time-wasting delays in the device product space. BIEL is not the only company disadvantaged by the government supposed to help expedite their growth!
What has made things more embarrassing is that the state of Maryland gave the company a grant to advance its business overseas and it has with OTC regulatory approval from Health Canada and in the UK! Are we crazy? No, just late! Hopefully the public meeting with the FDA in April will allow this little company to become a winner. No one else can bring the products to market - they're patented! Between the government and the FDA, we can't get out of our own way and the American people lose again. Maybe the FDA can save face by blaming DC......
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