Patients gave blood serum samples prior to the treatment in 1992 and one year later in 1993. They were immunoassayed for specific IgE products antibodies using a chemi-luminescent technique. Statistician Bradley Rosebrook for ran T-Tests comparing average baseline IgE levels to one-year. For the seasonal allergens reported, the active group (n=34) had on average a greater reduction in IgE than the placebo group (n=33).7 On August 14, 1996 representatives of Broncorp, Inc. met with the Division weight and loss Director, Dr. John Jenkins, and 14 other FDA officials of the Pulmonary Division at a PreNDA meeting. Dr. Mansfield made a presentation on the 1995 study data (n=165) from Oregon, products and for Washington and Idaho. He noted that together weight and loss the data failed to show statistical superiority of vitamin B12 on the primary endpoint. He noted that in Washington and Idaho, during the products later part of for the study, there was a drop weight in the pollen loss counts products and marked improvements in symptoms in both the vitamin B12 and placebo groups. (This made a therapeutic for benefit of the B12 treatment difficult to demonstrate.) weight But that the pollen counts in Oregon remained higher throughout the study and that the data from Oregon showed a significant difference between the active and placebo loss groups.8

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