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FDA Indecision PDT August 31, 2005 February 21, 2006 FDA takes conflicting positions FDA decides to apply PDT to all nasal sprays and Roslin passes October 2004 FDA applies DMR and fails Roslin April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 1 FDA Indecision PDT 1999 Nasal Spray Draft Guidance DMR 2 FDA Indecision PDT 1999 Nasal Spray Draft Guidance March 2000 Roslin asks for “goalposts” DMR 3 FDA Indecision PDT October 3, 2002 Roslin submits application 1999 Nasal Spray Draft Guidance March 2000 Roslin asks for “goalposts” DMR 4 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application 1999 Nasal Spray Draft Guidance March 2000 Roslin asks for “goalposts” DMR 5 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application 1999 Nasal Spray Draft Guidance March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 6 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 7 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 8 FDA Indecision PDT October 2004 FDA applies DMR and fails Roslin April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 9 FDA Indecision PDT August 31, 2005 FDA takes conflicting positions October 2004 FDA applies DMR and fails Roslin April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 10 FDA Indecision PDT August 31, 2005 February 21, 2006 FDA takes conflicting positions FDA decides to apply PDT to all nasal sprays and Roslin passes October 2004 FDA applies DMR and fails Roslin April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 11 FDA Indecision PDT August 31, 2005 February 21, 2006 FDA takes conflicting positions FDA decides to apply PDT to all nasal sprays and Roslin passes October 2004 FDA applies DMR and fails Roslin April 2003 Nasal Spray Draft Guidance October 3, 2002 Roslin submits application May 19, 2004 1999 GKE Citizen Petition Nasal Spray Draft Guidance July 26, 2004 Weller Citizen Petition March 2000 Roslin asks for “goalposts” May 1, 2004 Weller Citizen Petition DMR 12