Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



2011 No Dreamboat for MannKind

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

As binary events go, they don't get much bigger than decisions on Food and Drug Administration marketing applications. They can change the fortunes of a company in the blink of an eye, or at least however long it takes to read the letter from the FDA.

Imagine how different MannKind's (Nasdaq: MNKD  ) 2011 would have been if it had gotten its inhaled insulin Afrezza approved in January. This article would be about whether the company was hitting its sales figures.

Instead MannKind ends the year down 66%, even more if you measure from the peak of the run-up into the FDA decision. About the only good news is that the stock is up about 20% from the doldrums of August. Maybe investors are gaining confidence that the drug will gain FDA approval on its third attempt.

You'll recall that the complete response letter in January was actually MannKind's second. The first requested more information on the clinical utility of Afrezza; we'll blame that one on the FDA. The second seems to be MannKind's fault. The company switched to a better inhaler and tried to convince the FDA that laboratory tests should be sufficient to approve the new device.

It wasn't. The agency wanted data from actual humans taking the drug.

After a blessing from the FDA on two new clinical trials to prove that the new device works as well or better than the old one, MannKind got the trials started. If the company can enroll the trials quickly, they could be completed by the end of next year.

I don't think the risk here is that the trials won't be a success. Data from trials using Afrezza to date has looked pretty good. The bigger issue is whether MannKind can get the trials enrolled quickly. The current cash and a credit facility should last through the first quarter of 2012. That's not much leeway.

A quick enrollment would also give investors confidence in the commercial prospects for Afrezza; if patients are interested in trying it out in a clinical trial, more are likely to be interested once it's on the market. Pfizer's (NYSE: PFE  ) inhaled insulin Exubera was a commercial flop, and while Afrezza is arguably a much better product, there's still a worry that diabetics will shun an inhaled insulin product, being content enough to stick themselves with needles of insulin made by Novo Nordisk (NYSE: NVO  ) , Eli Lilly (NYSE: LLY  ) , Sanofi (NYSE: SNY  ) , and others.

If you're looking for something a little less dependent on binary events for next year, check out the Fool's new free report, in which Fool analysts report their top pick for 2012. Just click here to grab your free copy.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Pfizer. Try any of our Foolish newsletter services free for 30 days. We Fools may not 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.

Read/Post Comments (0) | Recommend This Article (3)

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.

Compare Brokers

Fool Disclosure

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: 1749041, ~/Articles/ArticleHandler.aspx, 10/26/2016 4:11:40 AM

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...

Today's Market

updated 6 hours ago Sponsored by:
DOW 18,169.27 -53.76 -0.30%
S&P 500 2,143.16 -8.17 -0.38%
NASD 5,283.40 -26.43 -0.50%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/25/2016 4:00 PM
MNKD $0.53 Down -0.03 -4.79%
MannKind CAPS Rating: *
LLY $77.75 Up +0.18 +0.23%
Eli Lilly and Co. CAPS Rating: ***
NVO $40.33 Down -0.48 -1.18%
Novo Nordisk CAPS Rating: *****
PFE $32.28 Up +0.15 +0.47%
Pfizer CAPS Rating: ****
SNY $37.39 Down -0.37 -0.98%
Sanofi CAPS Rating: *****