Vanda Pharmaceuticals had received considerable attention and improved valuation for tasimelteon, whose NDA has been filed in the treatment of circadian rhythm disruption associated with blindness. Now, Adam Feuerstein (Street.com) has outlined in devastating detail what went into the making of that NDA sausage, and it is indeed unappetizing. Vanda’s PR regarding the trial data did not acknowledge what appears to have been a change of primary endpoints even as the trials were ongoing–‘total nighttime sleep” turning into the “worst quartile of all their sleep;” the use of arbitrary cutoffs for nonvalidated measures not agreed to by the FDA beforehand; and the shoehorning of results into statistically significant range via the post hoc combination of patients from the randomized and screening components of the study. For those of strong stomach and curious mind, we refer you to Feuerstein’s article (http://www.thestreet.com/story/11954365/2/vandas-sleep-disorder-drug-is-a-nightmare.html). For NIR, Vanda has long epitomized the nightmare of wasted resources; their CEO received our coveted ‘Worst CEO of the Year’ for 2008, followed by ‘Luckiest CEO of the Year‘ in 2009, after Fanapt’s miraculous approval. His luck may be approaching its finite limit, even as he and his poor excuse for a BOD have run Vanda into the ground. Ordinarily, NIR takes a dim view of shareholder lawsuits, but in this case, one seems inevitable and justified.
*apologies to Thomas Dolby (1982)