It looks like Bristol-Myers Squibb
The agency wants more data to assess the risk-benefit profile for dapagliflozin. Ongoing studies might be enough, but there's a good possibility that another clinical trial might be necessary. If they're on the fence about an approval after 5,000 patients have been treated with the drug, somehow I doubt one more trial is going to make a difference.
There's still a lot of potential for dapagliflozin because it's a first-in-class molecule. Bristol-Myers and AstraZeneca's other diabetes drug Onglyza has been a relative flop because it acts in the same way as Merck's
Of course, being first in class has its drawbacks. While the companies didn't say, the aforementioned risk-benefit profile almost certainly has to do with dapagliflozin's potential cancer risk. The FDA advisory committee voted 9-6 recommending against approving the drug in large part because of nine cancers seen in patients taking dapagliflozin. While that's not enough to prove that there's a higher cancer risk, the FDA doesn't need another Avandia. A lot of patients took GlaxoSmithKline's
Bristol-Myers and AstraZeneca are in a bit of a bind because proving that a drug doesn't have a side effect can be difficult. But after so much time and money was put into the development, the duo is likely in too deep to just give up and throw dapagliflozin on the shelf.
At least Bristol-Myers and AstraZeneca offer attractive dividend yields for investors to collect while they wait to see next move for dapagliflozin. And if you like tasty dividends, take a look at a select group of dividend companies Fool analysts believe are good buys in this new report: "Secure Your Future With 11 Rock-Solid Dividend Stocks." You can get your copy for free by following this link.