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Patients gave blood serum samples prior to the treatment in 1992 and one year later in 1993. They were immunoassayed for specific IgE antibodies using a chemi-luminescent technique. tree Statistician Bradley Rosebrook ran T-Tests comparing average baseline IgE oils levels to one-year. For the seasonal tea allergens reported, the tree 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 oils and tea 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, Washington and Idaho. He noted that together the data failed to show statistical superiority of vitamin B12 on the primary endpoint. He noted that in Washington and tree Idaho, during the later part of the study, there was a drop in the pollen counts and oils marked improvements in symptoms in both the vitamin B12 and placebo groups. (This made a therapeutic benefit of the B12 treatment difficult to demonstrate.) But that the pollen counts tea in Oregon remained higher throughout the study and that the data from Oregon showed a significant difference between the active and placebo groups.8

Patients gave blood serum samples prior to the treatment in 1992 and one year later in 1993. They were immunoassayed for specific IgE antibodies using a chemi-luminescent technique. tree Statistician Bradley Rosebrook ran T-Tests comparing average baseline IgE oils levels to one-year. For the seasonal tea allergens reported, the tree 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 oils and tea 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, Washington and Idaho. He noted that together the data failed to show statistical superiority of vitamin B12 on the primary endpoint. He noted that in Washington and tree Idaho, during the later part of the study, there was a drop in the pollen counts and oils marked improvements in symptoms in both the vitamin B12 and placebo groups. (This made a therapeutic benefit of the B12 treatment difficult to demonstrate.) But that the pollen counts tea in Oregon remained higher throughout the study and that the data from Oregon showed a significant difference between the active and placebo groups.8

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