Chelsea Therapeutics (CHTP) just got Northera through the hurdle of the Advisory Panel, and the recommendation to the FDA has CHTP set to open Wednesday trading up 160%.
However, the FDA will make its final decision on the neurogenic hypotension treatment on Feb. 14, and despite the fact that Northera had been granted priority review, that’s certainly no guarantee the FDA feels like it has to give the drug the nod. Remember, the panel recommended the same drug be approved back in early 2012, and the Food and Drug Administration surprised a lot of CHTP stock owners by rejecting the drug, sending Northera back to the drawing board.
Perhaps the clarifying studies done in the meantime will appease the final authorities this time around. What’s at stake is at least $300 million in annual sales, according to some industry experts. An approval could make CHTP stock one of the most explosive biotech stocks of 2014.