Up 40%! Is Approval a Done Deal?

I'll be absolutely shocked if Onyx Pharmaceuticals' (Nasdaq: ONXX  ) carfilzomib doesn't get approved next month. The multiple myeloma drug, which will go by Kyprolis when it's approved, received an 11-0 recommendation for approval, with one abstention, from the Food and Drug Administration advisory committee yesterday.

But that's not why I think it'll be approved.

It's the agency, and not the panel of outside experts, that has the final say in whether a drug is approved. Listening to the meeting yesterday, it was pretty clear that the FDA was fairly fond of the data. More than once, the agency seemed to come to Onyx's rescue when the committee members asked questions during the meeting.

That's in stark contrast to the briefing documents, which seemed considerably more critical of carfilzomib.

In retrospect, there was one clue that the FDA might be more positive than the briefing documents made it appear. As I pointed out in my preview of the meeting, there were no discussion questions before the voting question. The FDA usually has preplanned questions about lingering issues it has about the drug before the voting question on whether to approve the drug. For example, here's a breakdown of the questions at the last few drug advisory committee meetings.

Drug Company Non-voting questions Voting questions
Carfilzomib Onyx 0 1
Semuloparin Sanofi 1 1
Tafamidis Pfizer (NYSE: PFE  ) 4 3
Rivaroxaban Johnson & Johnson (NYSE: JNJ  ) 7 1
Quad Gilead Sciences (Nasdaq: GILD  ) 3 1
Lorcaserin Arena Pharmaceuticals (Nasdaq: ARNA  ) 4 1
Source: www.FDA.gov.

At the time, I figured the lack of discussion questions might make it tougher on Onyx, with no chance for the drug's supporters on the panel to pull those on the fence onto their side. Instead, it looks like it was a sign that the FDA had nothing interesting to specifically ask the panel about.

I'd be careful extrapolating from Onyx's win the next time there's only a voting question. I don't think we have enough data points; this is the only example I can remember when there weren't any additional questions. And just because the FDA doesn't have any specific questions, doesn't necessarily mean that the reviewers haven't figured it all out, and convinced themselves that the drug isn't worth approving.

The biggest binary event, the presidential election, is around the corner, and it's time to prepare now. Check out the Fool's new free report, "These Stocks Could Skyrocket After the 2012 Presidential Election," where you'll get ideas for companies that can benefit from each candidate's platform. Get your free copy by clicking here.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Pfizer, Gilead Sciences, and Johnson & Johnson and recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool's disclosure policy thinks there should be discussion questions before election votes.
 
We Fools may not all hold the same opinions, but we all believe that
considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 1920718, ~/Articles/ArticleHandler.aspx, 12/21/2014 3:21:30 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement