Chelsea Therapeutics (NASDAQ:CHTP) Regulatory Timelines Accelerated

With Study 306 no longer considered pivotal for Droxidopa NDA, the timeline for Chelsea Therapeutics (NASDAQ:CHTP) should be shrunk by a quarter.

Needham said, "Chelsea management announced this morning that, as a result of recent pre-NDA meetings with the FDA, the company now plans to submit a Droxidopa NDA based on data from only the first two Phase 3 trials (Studies 301 and 302). The ongoing Study 306 is no longer considered a pivotal study. This is expected to accelerate regulatory timelines by about a quarter, allowing NDA submission in 2Q11. The news appears to reflect interest by the FDA in finding a suitable replacement for midodrine, which the FDA is seeking to pull from the market. We caution investors, however, that outcome of the ongoing Study 306 is still likely to influence FDA review. Consequently, although we are favorably inclined with respect to Study 306 outcome, clinical trial risk (in addition to regulatory risk) still must be factored in the stock."

Needham & Company maintains a "Buy" rating on Chelsea Therapeutics, which closed Monday at $7.69, up $1.68, or 28.02 percent. Needham has a price target on them of $10.