Biodel shares plunge after FDA demands two new Ph3 trials

The FDA is requiring Biodel to essentially go back and start a late-stage development program from scratch.

After fretting for months that Biodel (BIOD) didn't have the data needed to gain an approval for its fast-acting insulin Linjeta, analysts discovered this morning that the FDA is requiring the company to essentially go back and start a late-stage development program from scratch. Regulators say Biodel will need to conduct two late-stage studies for Type 1 and Type 2 diabetes in order to deliver the efficacy and safety data needed for an approval. The news caused Biodel's shares to plunge by more than half.

Regulators determined that Biodel's decision to exclude Indian trial data for the Type 1 study "was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy," according to the company's release. "In the Type 2 trial analysis, the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc mo