Toxicology/Pharmacology. The currently available toxicology package includes both a 3-month rat and a 3-month monkey study. In order to proceed with longer term clinical studies, we anticipate conducting the following studies: · 12-month rat study · 12-month monkey study In addition, prior to NDA submission, we need to plan and conduct a 24 month rat carcinogenicity study. Studies will have to be conducted to quantitate anti-BA058 antibody production and development of neutralizing antibodies.
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Samples: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)
Toxicology/Pharmacology. The currently available toxicology package includes both a 3-month [*]-month rat and a 3-month [*]-month monkey study. In order to proceed with longer term clinical studies, we anticipate conducting the following studies: · 12-month [*]-month rat study · 12-month [*]-month monkey study In addition, prior to NDA submission, we need to plan and conduct a 24 [*] month rat carcinogenicity study. Studies will have to be conducted to quantitate anti-BA058 antibody production and development of neutralizing antibodies.
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