Biotech Values

[DewDiligence]

FDA demands new phase-3 trials for BIOD’s Linjeta:

Key question here is if they can get the FDA to ignore some of the data from one of their India-based trials. If you throw out that data, then their trial succeeded, if not, it failed to show non-inferiority.

The FDA did not accept the post-hoc exclusion of data from India, but this was far from the only problem:

http://finance.yahoo.com/news/FDA-Issues-Complete-Response-prnews-1215523873.html?x=0&.v=1

With regard to efficacy, the FDA stated that, in the type 1 trial analysis, excluding data from India was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy. 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 modification of the statistical model as establishing conclusive evidence of efficacy.

With regard to safety, the FDA commented that unequivocal non-inferiority needs to be achieved in order to compare the risk of hypoglycemia. The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration.

CC at 8:30am ET. Ouch for BIOD longs.