I spoke briefly with Chelsea Therapeutics' (CHTP) CEO Joe Olivetto this morning about Tuesday's positive Northera FDA advisory panel and next steps for the company.
For those who missed it, the FDA panel voted 16-1 to recommend the approval of Northera for the treatment of neurogenic orthostatic hypotension (NOH), a chronic disease characterized by dangerously low blood pressure.
The FDA approval decision date for Northera is Feb. 14. FDA rejected Northera following a positive panel vote in 2012, so there are no guarantees. However, I believe it will be much more difficult for FDA to reject Northera again. Two positive panels following a very thorough presentation and discussion of all the issues with the Northera clinical data justifies an FDA approval.
That's how I see it.
Anyway, back to Olivetti's comments from our quick chat this morning.
His reaction to Tuesday's panel:
I was very happy with the outcome. Even with the vote being dramatically positive, you still worry about mis-understandings. Did the panelists get it? Did they understand the issues? Was the vote based on mis-perceptions? I don't think we saw any of that. The panelists did a great job. They were prepared and they dove right in.
On the company's strategy going into the panel and why the panelists votes to recommend Northera's approval:
We had been discussing the issues about Northera with the FDA for awhile so there were no surprises. We were prepared to discuss the issues and articulate them as clearly as we could. And the panelists were also really prepared....