Before we start giving high-fives and inviting our new best friends at the FDA to sit around the campfire singing "Kum-ba-yah," let's keep this in perspective. These approvals definitely don't mean the FDA is becoming more lenient.
This wasn't Bristol-Myers' first attempt to gain FDA approval for Nulojix. Despite a solid 13-5 endorsement of Nulojix by the FDA advisory panel, the agency ignored the majority of outside experts and asked for additional safety data before it would approve the drug. Sure, the drug got approved eventually, but Bristol-Myers missed out on a year of revenue in the process.
It was Potiga's second attempt at an approval as well, although Valeant and Glaxo didn't have to wait as long to gain approval. The FDA turned down the drug late last year for non-clinical reasons, which helped facilitate the quicker return to the jury room.
Recent FDA endorsements of hepatitis C drugs by Merck
At this point, unless the drug has solid data and treats a disease with limited treatment options, investors should continue to expect a high probability of a first-approval rejection.
Fool analysts expect the government to be much kinder to some companies. Grab the free report "Too Small to Fail: Two Small Caps the Government Won't Let Go Broke" to see which ones.
Fool contributor Brian Orelli holds no position in any company mentioned. See his holdings and a short bio. The Motley Fool owns shares of GlaxoSmithKline. Motley Fool newsletter services have recommended buying shares of GlaxoSmithKline and Vertex Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.