Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Biodel Inc. BIOD -1.67% today announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia.
Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the FDA is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during the second half of 2014, putting the Company in a position to file an NDA to the FDA under the 505(b)(2) regulatory pathway in 2015.
http://www.marketwatch.com/story/bi...e-treatment-of-severe-hypoglycemia-2013-06-06
Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the FDA is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during the second half of 2014, putting the Company in a position to file an NDA to the FDA under the 505(b)(2) regulatory pathway in 2015.
http://www.marketwatch.com/story/bi...e-treatment-of-severe-hypoglycemia-2013-06-06