) -- I ate three pounds of Halloween candy this week but was still able to write the Biotech Stock Mailbag.
Let me start by recapping my recent history with
and Northera, the experimental treatment for neurogenic orthostatic hypotension (NOH) -- a chronic disease characterized by dangerously low blood pressure. I predicted a positive vote from the experts on the
February 2012 FDA advisory panel
Despite a highly skeptical FDA review and some really hairy Northera data, the panel voted 7-4 to recommend the drug's approval. Yeah for me!
The positive panel vote prompted me to follow up with a column titled,
Five Reasons Chelsea Therapeutics' Northera Will Get FDA Approval.
And then FDA rejected Northera in March 2012. F---k me.
Here we go for round two. Chelsea is bringing Northera in front of a second FDA advisory panel on Jan. 14. Like the last time, the panel experts will be asked to weigh in the risk-benefit of approving Northera for the treatment of NOH. Unlike the last panel, Chelsea arrives this time armed with more Northera clinical data from a second phase III study which the company hopes will convince the panel AND the FDA that the drug deserves approval.
Let's dig into some of these new Northera data and discuss the issues likely to come up at the Jan. 14 panel. I spoke with Chelsea CEO Joe Oliveto this week to get his take as well.
First, my prediction: The FDA panel will vote to recommend Northera's approval. The vote will be more decisive in Northera's favor than the last time. I'll hold off on predicting the FDA's ultimate decision (due Feb. 14) but if the panel goes well for Chelsea, it will be more difficult for the agency to say no a second time.
The following slide describes the primary endpoint of the two phase III studies evaluating Northera in NOH patients:
Recall, Study 301 is the older Northera clinical trial discussed at the first advisory panel and already reviewed by the agency, ultimately deemed insufficient to warrant approval.