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Tuesday, December 01, 2015 3:31:45 PM
No sir/madam. BIEL was not granted FDA OTC approval, which is the main reason why the stock is selling off.
Remember, the FDA is obligated to inform BIEL, in writing, the reasons for not being granted approval at 100 days after the submission date.
BIEL knows the reasons for not being granted approval, they have written confirmation of the reasons for not being granted approval.....they are just not sharing this information.
Check the FDA website....the FDA must communicate with the submitter of the 510k at 100 days since the submission date. The FDA is obligated to provide written confirmation explaining why approval has not been granted. BIEL knows the truth.....while supporters chose to ignore this fact, the stock is selling off big time.
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