Albireo (ALBO)

[ronpopeil]

Another good post about BIOD from the yahoo board

Press release early last year.

Biodel's chairman and chief executive officer, Dr. Sol Steiner, stated:


"After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject(R) in the second half of this year. This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal Phase 3 clinical trials, which we believe met the endpoint of non-inferior change in HbA1c over six months. In the meantime, we continue to collect safety data from the open-label extensions of the Phase 3 trials and are proceeding with plans to conduct additional development work this year to further differentiate VIAject(R) from the rapid-acting insulin analogs."

Let look at that again: "After investigating the cause of the anomalous data in India and discussing our findings with the FDA..."

There have been at least 3 meetings with the FDA after the data came out.

In addition this is a 505b2 application.


No issue