What are those warning signals?
Skimping on Phase II studies, borderline statistical significance, lack of a sensible dose-response curve, post-hoc analyses of subsets of data, indications that have proven hard in the past (like sepsis, shock and ARDS), pharma partners that have "enabled the company to reacquire its rights", multiple previous failures by the company, sudden talk about backup compounds, unusually slow enrollment in studies, sudden need for more animal studies late in the game, and skepticism by people like Miljenko and Rick who are blessed with a good nose.
Of course sometimes you just get blindsided - for example, the deaths in Biogen's Phase II of their CD40 project seemed to come out of the blue and may have killed one of the most promising compounds in all biotechland.
Peter |
