Biotech Values

[DewDiligence]

SPA in action:

As long as we are talking about diabetes…

At today’s AMLN CC, the company disclosed that the design of the four pivotal Exenatide trials was submitted to a Special Protocol Assessment (SPA) by the FDA. Moreover, the FDA recommended several protocol changes which the company adopted.

Without the SPA, the complex set of pivotal Exenatide trials might have been considered a high-risk proposition for FDA approval on the first attempt. However, the SPA changes everything and makes Exenatide approval extremely likely.

I continue to beat the drum that companies which forgo an SPA for pivotal trials should be viewed by investors with a skeptical eye.