Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)

CAPS Rating: 2 out of 5

A development stage pharmaceutical company that seeks to acquire and develop innovative products for the treatment of a variety of human diseases.

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2
Player Avatar zzlangerhans (99.77) Submitted: 3/12/2013 2:46:01 AM : Underperform Start Price: $2.00 CHTP Score: +16.77

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.
Vanda's
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.

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