This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

How I Think About MannKind's Afrezza FDA Panel

MannKind (MNKD) will bring its inhaled, rapid-acting insulin Afrezza in front of an FDA advisory panel on April 1. [Insert April Fool's Day jokes here.]

In today's Biotech Stock Mailbag, I elaborated on my prediction that FDA would reject Afrezza. That was before the FDA panel announcement, so let's discuss further.

I see the scheduling of a panel for Afrezza as a MannKind negative, indicative of FDA's problems with the Afrezza data. At best, it's another risk that will hang over the stock until April 1.

I've always had my doubts about MannKind's ability to find a marketing partner for Afrezza, despite the company's assurances that negotiations were underway. It's hard now to see any potential partner taking on the risk of Afrezza in front of this FDA advisory panel.

Must Read: Chelsea Blues: FDA Reviewer Hates Northera But Don't Head For Exit Quite Yet (Corrected)

This morning on Twitter, healthcare investor (and TheStreet contributor) Aafia Chaudhry @aafiac argued the scheduling of a panel betters the odds of Afrezza approval, in part because 1) FDA almost never approves a diabetes drug without first holding a panel; and 2) A panel endorsement is absolutely necessary for a unique product like inhaled insulin. She implies that historically, experts on FDA panels have been more lenient and supportive of new diabetes drugs than the FDA itself.

Aafia's points are well taken but on balance, I still see more risk to MannKind because the Afrezza data are a black box. The only data investors have seen come via MannKind press releases. In April, we'll get a far more objective -- and critical -- take on the Afrezza data when FDA posts its review ahead of the April 1 panel.

I expect the FDA's briefing documents to raise a lot questions about the efficacy and safety of Afrezza. I think we'll also learn a lot more about the interactions between FDA and MannKind over the last several years, some of which won't put the latter in a favorable light.

I'm really looking forward to live-blogging this FDA panel. April 1 can't come soon enough.

-- Reported by Adam Feuerstein in Boston.  

Follow Adam Feuerstein on Twitter.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Adam's Tweets

Select the service that is right for you!

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
Real Money Pro

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Trifecta Stocks

Trifecta Stocks analyzes over 4,000 equities weekly to find the elite 1% of stocks that pass rigorous quantitative, fundamental and technical tests.

Product Features:
  • Model portfolio
  • Trade alerts
  • Recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Growth Seeker

Chris Versace, using sophisticated stock screening and fundamental research, identifies potentially explosive small and mid-cap stocks.

Product Features:
  • Model portfolio
  • Small-cap and mid-cap focus
  • Intraday trade alerts
  • Weekly roundups
Daily Swing Trade

Master swing trader Alan Farley uses his sophisticated software screens to review thousands of stocks each day for you, to find just the handful that meet his demanding criteria.

Product Features:
  • Daily commentary and coaching on swing trading
  • Technical charts and analysis
Top Rated Stocks Top Rated Funds Top Rated ETFs