Chelsea Therapeutics Intl Ltd fka CHIP

[KornPicker]

75% chance FDA approves Northera

Here we go again. Chelsea resubmitted Northera to FDA. This time, the approval filing includes data from another phase III study showing significant and meaningful reductions in dizziness and lightheadedness --- the FDA's preferred endpoint to measure clinical benefit in NOH patients. Chelsea still lacks data demonstrating durability of Northera's effect, but FDA appears willing to allow a post-approval trial to take care of this commitment.
FDA set Jan. 3, 2014 as the approval decision date for Northera. The agency also told Chelsea that it may bring the drug in front of a second advisory panel prior to making a final decision. The first panel voted in favor of Northera despite hairy data and an oppositional FDA. It's hard to envision a scenario under which a second panel -- presented with even more data confirming Northera benefit for NOH patients -- doesn't also vote to recommend approval.
I believe there's a 75% chance FDA approves Northera on the second go-around with Chelsea. The stock's current market value of less than $200 million does not fully account for the drug's approval and commercial market opportunity.

http://www.thestreet.com/story/11982642/3/biotech-stock-mailbag-sarepta-chelsea-ipo-fever.html