Chelsea's plan to change endpoint raises fresh doubts

A few weeks ago, Chelsea Therapeutics shares cratered after a late-stage study of its orthostatic hypotension therapy droxidopa--long considered a sure thing by many analysts--failed to hit its primary endpoint. In the ensuing panic, its stock plunged 76 percent [1].

Late yesterday the company told analysts that it had decided to sit down with regulators at the FDA and gain their blessing to change the primary endpoint of its second, ongoing Phase III trial for droxidopa, says TheStreet. And that will delay any announcement on topline results from later this quarter to early next year.

TheStreet's Adam Feuerstein, who had been upbeat on Chelsea's prospects after its share price had been hammered down, was left shaking his head.

"That strategy may work, but the maneuver also significantly changes the Chelsea-droxidopa story and raises the level of risk," he notes. "Instances are rare in which a company makes a radical change to a pivotal study midstream. It's not even clear if the FDA will allow the change to be made."

- check out the Chelsea release [2]
- read the story [3] from TheStreet

Related Articles:
Biotech motto: Be prepared for anything [4]
In a stunner, Chelsea's hypotension drug flunks Phase III [5]
Chelsea Therapeutics - Best Pharma Stocks of 2007 [6]