Ariad Pharmaceuticals (NASDAQ: ARIA ) could be listed here twice. Unfortunately, only half the surprises were positive, and the negative surely outweighed the rebound.
In October, Ariad said it was pausing and eventually stopping a clinical trial testing its leukemia drug, Iclusig, in the first-line setting because of the potential for blood clots. That wasn't particularly surprising given there were an unusually large number of blood clots in the pivotal trial used to gain FDA approval. A follow-up of those patients demonstrated it wasn't a fluke.
What surprised me was the Food and Drug Administration pulling Iclusig off the market while it figured out a population where the risks were worth the potential benefit. There were only 640 patients on the drug at the time; surely the agency could have figured out some other way to communicate the new information about potential side effects with doctors without pulling the drug from the market and making them go through special channels to acquire it.
Perhaps even more surprising is the speed at which the agency wrapped up its conclusions about who should get the drug, allowing Iclusig back on the market less than two months later. In retrospect, it shouldn't have been surprising since pulling the drug from the market seemed extreme, but if the agency was going to be that cautious to begin with, a long drawn-out process appeared inevitable.
Moral of the story: Never underestimate the perplexity of the FDA. Also be careful buying drugmakers with side effects in their pivotal trials that could come back and bite the company post-marketing. Despite being well off its 52-week low, Ariad Pharmaceuticals is nowhere near where it sat before this saga began.
http://www.fool.com/investing/general/2013/12/31/...aspx#.UsPgd2ZV-9M
Thread abonnieren
