Another day, another positive advisory panel recommendation. Too bad all positive recommendations aren't created equal.
Wednesday, an advisory panel recommended approving VIVUS'
The difference: VIVUS' win was 20-2; Chelsea's was just 7-4. Remember, the panel's vote is only a recommendation, so the margin of victory matters, as do the comments that the experts make during their vote.
Unfortunately for Chelsea, one panelist abstained and another just didn't vote. I'd feel a lot better about the FDA following the panel's advice if both of those had been positive votes.
The required margin of victory is dependent on the FDA's opinion going into the panel. If the FDA had been neutral to positive going into the advisory panel, I'd say a 7-4 win might be enough to push the agency towards approval. But the FDA's briefing documents were very tough on Northera's efficacy and safety data. The advisory panel members were much more level-headed, considering the unmet need; Shire Pharmaceuticals'
Biotech history is riddled with positive advisory panel recommendations that the FDA ignored. InterMune's
When Chelsea announced the FDA's concerns last week, I said there was more upside potential than downside risk and made a CAPScall giving it a thumbs-up. I ended that pick today after its monster jump. Northera could be approved, but the risk/reward doesn't look nearly as promising as it did yesterday.