CHARLOTTE, N.C. ( TheStreet) -- Chelsea Therapeutics (CHTP) shares closed Friday with a nice 61% pop, but at $3.88 per share, the stock still trades as if investors doubt the company's chances of receiving a first-pass FDA approval for it low-blood pressure drug Northera.
I watched and live-blogged all seven hours of Thursday's FDA advisory panel at which outside experts voted to recommend Northera's approval as a treatment for neurogenic orthostatic hypotension (NOH). From my view of the panel's proceedings, here are five reasons why FDA will approve Northera -- and why Chelsea shares aren't yet valuing the good news pending.
1. The 7-4 vote recommending Northera's approval was a big win. Yes, it was a split vote, even more so if you take the conservative route and place the one abstention and one non-vote into the "no" bucket. But those seven "yes" votes are more than Northera could have reasonably expected to garner given the FDA reviewer's sharp critique and outright recommendation not to approve.Chelsea did an exemplary job of wooing a roster of mostly cardiologists (naturally skeptical) to its side of the argument. These experts are accustomed to reviewing large trials with objective, easy-to-define cardiovascular endpoints. Thursday, these panelists were asked to pass judgment on a drug for an orphan disease assessed using mostly subjective endpoints like dizziness and lightheadedness. On top of that, the Northera data were messy. And still, seven votes in favor of approval, which included four cardiologists and a neurologist. Only one cardiologist voted against the drug. That's a persuasive argument for Northera's approval. 2. The presence of FDA honcho Dr. Robert Temple suggests FDA is open to approval. If FDA's decision makers unanimously agreed with the negative view of reviewer Melanie Blank and her team, there would be no impetus for Temple, FDA's Deputy Director for Clinical Science, to attend the panel meeting in person.
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