Editor's note: This article is a stock pitch made by a member on CAPS, The Motley Fool's free investing community. The pitch is published unedited and is the opinion of the CAPS member whose pitch it is, in this case: zzlangerhans.

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Company

Chelsea Therapeutics (NASDAQ:CHTP)

Star Rating (out of 5)

*

Industry

Biotechnology

Market Cap

$128 million

 

Chelsea Therapeutics Underperform Pick

Submitted By

zzlangerhans

Member Rating

99.56

Submitted On

3/12/2013

Stock Price At Underperform Recommendation

$2.00

Sources: S&P Capital IQ, Yahoo! Finance, and Motley Fool CAPS.

This Week's Pitch:

Chelsea is definitely the soapiest soap opera of biopharma. It's virtually impossible to keep track of the multiple trials, the changing endpoints mid-trial, the dubious and equivocal trial results, the company's nebulous plans for regulatory submissions, and the company's confusing descriptions of FDA communications regarding their trials and regulatory submissions. The only consistent outcome is that the binary catalysts constantly seem to find the market wrongfooted.

I think once again the market is taking Chelsea in the wrong direction, enthusiastically bidding up the share price on news that the FDA has reversed itself and stated that study 306B has the potential to serve as the basis for a Northera NDA resubmission. Of course, there's a big difference between serving as the basis for an NDA submission and the basis for an NDA approval. And the market seems to have forgotten that the 306B topline data was actually pretty bad, with no evidence of statistically significant benefit beyond the first week of treatment.

...The FDA has shocked me before, for example by reversing themselves and approving Vanda's Fanapt a few years ago. But in general I find it wiser to go with the FDA's usual approach to this type of weak NDA application rather than to bet on the black swan.

Fool contributor Dan Dzombak can be found on Twitter @DanDzombak or on his Facebook page, DanDzombak. The Motley Fool has no position in any of the stocks mentioned. 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.