Will Bydureon Gain FDA Approval?

The answer to the question in the title: Without a doubt, 100%, absolutely, a solid probably.

Unfortunately, we can't get any more confident than that. This is the Food and Drug Administration we're talking about here.

Before Amylin Pharmaceuticals' (Nasdaq: AMLN  ) second attempt at gaining approval for Bydureon, I wrote:

While I'll plant my flag in the camp expecting an approval, I'd caution investors not to go all-in here. It's not unprecedented for minor issues to trip up companies multiple times. Worse yet, we've seen the FDA come up with new issues even after having another six months to review the drug.

That still seems relevant 15 months later. Amylin appears to have crossed all its t's and dotted all its i's -- some that didn't need to be written in the first place -- but that seemed to be the case last time, too. The first rejection was for minor risk management and manufacturing issues; the second was for potential heart problems the drug might cause that weren't brought up in the first rejection. I have a hard time seeing either of those getting in the way of an approval, but there's just no way to know if the FDA can come up with something else to harass Amylin about. The risk is low, but an approval isn't guaranteed, either.

It's not just Amylin that has a stake in Bydureon's approval; both Eli Lilly (NYSE: LLY  ) and Alkermes (Nasdaq: ALKS  ) are rooting for an approval, too. Eli Lilly, Amylin's former partner, gets royalties on the drug, as does Alkermes, which contributed the extended-release technology.

Novo Nordisk (NYSE: NVO  ) is definitely not rooting for an approval. Bydureon's delay afforded Novo's Victoza time to penetrate the market. But Victoza's victory should be short-lived, as it's a once-daily medication, whereas Bydureon's once-weekly formulation allows for far fewer shots in the arm.

That's my take. How do you size up Bydureon's chances of gaining an approval on its third shot? Take the poll and tell us your reasoning in the comment box below.