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Page 1: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 2: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 3: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 4: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 5: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 6: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 7: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
Page 8: Food and Drug Administration · These include a pre-sNDA meeting package and correspondences dated I I July 2008, 19 August 2008, 18 September 2008, 6 October 2008 and 14 October
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(b) (4)

(b) (4)

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(b) (4)

(b) (4)(b) (4)

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(b) (6)

(b) (4)

(b) (4)

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(b) (6)

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(b) (6)

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(b) (4)(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

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(b) (4)

(b) (4)

(b) (4)(b) (4)

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(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

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