Biotech Values

[p3analyze]

>>example of bad decision making<<

LLY was probably planning to deliver a knock-out punch by showing superiority once non-inferiority (NI) can be established. Therefore, NI must be the worst-case or base case strategy their marketing folks have planned. This reminds of the trial of Panitumumab in first-line mCRC in avastin and chemo combo, where Amgen was said to go for the jugular vein in the race against Imclone. Unfortuantely the study did not pan out. In Amgen's case, not only did Panitumumab not show a benefit, but also showed significant survival detriment.

The company should carefully examine study conduct and answer why the effect size in duration-6 has differed so much from previous trials. We know both LLY and AMLN have cut back significantly on in-house clinical trial monitoring staff, following the industry trend, and outsourced clinical trials to CRO, who I always question whether these for-fee service vendors who are inadequately resourced to ensure a profit margin can do as good a job as the sponsor who may be more diligent monitoring. Since duration-6 was an open label trial, therefore, any study conduct and compliance issues at the physician and patient level if not caught early could affect the trial outcome.