POZEN (POZN) dropped in pre-market trading, after the FDA informed the company that it's about to conduct an internal review of gastric ulcers used as a primary endpoint in clinical trials.
The stock was down $2.00 just before 9:15 am ET, declining to $7.00. If pre-market losses hold, the stock will open at its lowest level since July 2006.
POZEN announced that the U.S. Food and Drug Administration informed it about conducting an internal review on the acceptability of using endoscopic gastric ulcers as a primary endpoint in clinical studies. This was as part of the FDA's on-going discussions with the company and their review of both the Special Protocol Assessment for PA32540 and the Statistical Analysis Plan for PN 400.
The company said it has been advised by the FDA that an internal meeting could take place on this matter as soon as the FDA can gather all the interested parties together. However it did not expect that to happen until the first quarter of next year.
For comments and feedback: editorial@rttnews.com