Memorandum, June 1, 2011 - Spherusol
Date: June 1, 2011
- From information contained in our Information Request letter of May 11, 2011 and information in Table Q5-1, Study 101A, located on page 25 of 66 in your “Response to FDA BLA Review Letter dated March 26, 2010” contained within your May 28, 2010 submission, it appears that only 10 of 20 subjects in study S101A returned a subject diary card. Please confirm that only ten of the 20 subjects returned subject diary cards during the conduct of this study.
- We note that although Subject --(b)(6)-- graded the ulceration at the skin test site as mild in Study S104-2, he received medical treatment for the ulceration from the attending physician [Elocon (Mometasone Topical) for two weeks]. This adverse event meets the definition of a severe adverse event. Please revise Table 3-2 on page 5 of 16 in your “Response to FDA Letter dated May 11, 2011” contained within your May 27, 2011 submission to your BLA, to account for this grade 3 adverse event.
- We note in Table 3-2 on page 5 of 16 of your “Response to FDA Letter dated May 11, 2011,” contained within your May 27, 2011 submission to your BLA, that 2 subjects reported difficulty breathing and shortness of breath; one mild and one moderate in intensity. However, the total number of subjects reporting any difficulty breathing/shortness of breath is given as one. Please revise the table to show that 2 subjects reported difficulty breathing and/or shortness of breath.