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June 13, 2006
Disapproval of Approvability
I've written before about how seemingly obvioius combination therapies can be hard to develop. Last Friday we had some more evidence of that.
Pozen, partnering with GlaxoSmithKline, has been trying to put together two well-established drugs for migraine: GSK's Imitrex (sumitriptan) and the OTC pain reliever naproxyn. But the FDA sent them the dreaded "approvable" letter, requesting more information (which, who knows, might require more studies) and Pozen's stock took the plunge. (Another small company, Neurocrine, went through a similar wringer a couple of weeks ago - I'm backed up on writing about that, but I hope to soon).
Analysts seem to be optimistic about the drug's eventual chances, but that doesn't do you as much good if you were holding the stock before the FDA letter. These "approvable" letters seem to have been increasing in frequency the last couple of years, and it's turning into a real problem. Such a letter either turns out to be not too big a deal, in which case a company's stock has been slaughtered for nothing, or it turns out to be such a big deal that you wonder why the company (and the agency) didn't come to some understanding about it before.
Is the FDA too risk-averse, or are companies trying to get too-thin NDAs through? My money's on the first explanation, in most cases. I think that the whole COX-2 debacle has helped to put the agency into a better-safe-than-sorry mode. I understand the need for caution, but (here comes a general principle of life): just because you can mess things up in one direction doesn't mean that you can't mess them up in the opposite one. Saying that the agency is too cautious doesn't mean that I think that they should let everything through - but letting some things through would be nice.
(See this Business Week piece for more on the approvable problem).
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