Biotech Values

[DewDiligence]

Did anyone notice that BIOD, a biotech company, was off 66% today?

http://biz.yahoo.com/bw/080908/20080908005463.html

What happened? Two clinical trials in type-1 and type-2 diabetes, respectively, showed non-inferiority to an inferior regimen. Seriously.

In both trials, the drug to which BIOD’s VIAject was compared was LLY’s Humulin, which is just a brand name for ordinary human insulin—hardly the standard of care these days.

The BIOD trials also had a rather serious data-integrity problem at the trial sites in India (a recurring problem with trials run by small biotech companies). In fact, it was only by excluding the sites in India that the trials supposedly achieved statistical significance on the primary endpoint. Obviously, such a post hoc geographic exclusion won’t pass muster with the FDA or any other major regulatory body.