Wednesday, March 05, 2014 12:36:18 PM
The fabulous position BIEL is now in, by comparison, is that the FDA has created a 'new' device category that BIEL can apparently slide into.
Cudos to the FDA for creating this category for any company applying for approval for a drug-free product. BIEL's products are also side-effect free and patented, does it get any better?
Also, I don't think anyone is arguing - a lot happened in 2009 and the price went from .004 to over 12 cents on the 'assumption' that applying for approval was approval. At the time BIEL's application was flawed, the data was incomplete, management handled the issues poorly and there was no category for its products, all leading to denial.
Now, the great opportunity is very clear to those in the know - there is now a new category for BIEL products created by the FDA itself and hopefully to be implemented in a couple of months; BIEL is ready to resubmit an application for approval of its products for OTC sales in the US; BIEL has expanded its product line; it's still drug-free and side-effect free and it is believed that management now has the necessary horsepower to move forward with experts involved.
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