By: Adam Feuerstein | 02/12/14 - 09:41 AM EST
Friday is when the FDA is expected to make its approval decision on
Chelsea Therapeutics' CHTP Northera for the treatment of neurogenic orthostatic hypotension (NOH), a chronic disease characterized by dangerously low blood pressure.
I'm getting a bunch of emails asking for my prediction, so here it is:
FDA will approve Northera on Friday. Odds? I give it 70%.
Why not be more confident? Because there's a small chance FDA delays the Northera decision given the short amount of time between Friday's approval decision date and last month's positive advisory panel. A short delay for administrative reasons -- meaning no requirements for additional clinical data -- won't matter much and may actually benefit Chelsea since the orphan indication clock doesn't start ticking until approval.
I interviewed Chelsea CEO Joe Olivetto after the FDA advisory panel voted 16-1 to recommend Northera's approval. The interview is worth another read, in my humble opinion.
I did fail to mention or ask Olivetto about his desire to sell Chelsea if Northera is approved, although he's been rather vocal about the considering placing the company on the auction block instead of moving ahead with a commercial launch of the drug on its own. No doubt, the question about seeking a buyer will be asked by someone on the Northera post-approval conference call. Listen for that.
Here's the year-to-date performance chart for Chelsea tracked against the Nasdaq Biotechnology Index:
CHTP data by YCharts
A Northera approval Friday will be more good news for Chelsea, as long as FDA doesn't saddle the drug with significant use restrictions. What Chelsea and its supporters don't want to see is an FDA-approved label which says Northera should not be used longer than 1-2 weeks.
11/19/14 - 01:25 PM EST
11/18/14 - 10:16 AM EST
11/13/14 - 04:34 PM EST
11/10/14 - 10:40 AM EST
11/06/14 - 11:31 AM EST
11/22/14 - 14:07 PM EST
11/21/14 - 10:53 AM EST
11/20/14 - 12:55 PM EST
11/20/14 - 11:38 AM EST
11/20/14 - 09:55 AM EST
Access the tool that DOMINATES the Russell 2000 and the S&P 500.