Quarterly report pursuant to Section 13 or 15(d)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2017
Sep. 30, 2016
Sep. 30, 2017
Sep. 30, 2016
Income Statement [Abstract]        
Product sales, net $ 5,591,210 $ 2,939,997 $ 13,437,233 $ 7,850,430
Cost of goods sold 1,593,561 1,051,048 4,162,122 2,671,519
Gross Profit 3,997,649 1,888,949 9,275,111 5,178,911
Operating Expenses:        
Selling, general and administrative (4,311,078) (3,072,441) (11,513,560) (9,147,411)
Research and development (179,338) (396,238) (573,701) (879,598)
Total operating expenses (4,490,416) (3,468,679) (12,087,261) (10,027,009)
Gain on changes in derivative liabilities 10,987 0 248,875 0
Royalty buy-out 0 0 (2,432,000) 0
Total operating expenses (4,479,429) (3,468,679) (14,270,386) (10,027,009)
Operating Loss (481,780) (1,579,730) (4,995,275) (4,848,098)
Other (expense) income:        
Interest income 0 0 7 27,658
Interest expense (108,203) (321,006) (371,678) (840,315)
Total Other (Expense) Income (108,203) (321,006) (371,671) (812,657)
Loss before provision for income taxes (589,983) (1,900,736) (5,366,946) (5,660,755)
Provision for income taxes 0 0 0 0
Net Loss $ (589,983) $ (1,900,736) $ (5,366,946) $ (5,660,755)
Weighted average common shares outstanding - Basic and Diluted 88,114,604 52,218,272 77,126,737 51,362,444
Net Loss per common share - Basic and Diluted $ (.01) $ (.04) $ (.07) $ (.11)