Well, maybe. But that’s the implication, according to Dave Amsellern, a Friedman Billings Ramsey analyst, now that the FDA has scheduled a meeting for its Gastrointestinal Drugs advisory committee to review the med on Jan. 23, less than three weeks before the Feb. 10 PDUFA date (which, of course, is when the new drug application turns into a pumpkin). The meeting date was announced by Glaxo and Adolor, which have been laboring to win FDA approval for Entereg, which would be used to treat post-operative ileus, or bowel dysfunction after surgery.

However, the drugmakers have run into repeated delays - two approvable letters were issued and clinical trials were halted after Entereg was linked to a higher risk of heart attacks and other serious heart problems, fractures and skin cancers. Nonetheless, Glaxo and Adolor last summer submitted additional data to the FDA in hopes of salvaging the med, which at one time was expected to generate $400 million in annual sales just for Glaxo. Originally, the drugmakers are seeking approval for treating constipation caused by opioid painkillers, a larger market.

“The meeting suggests a glimmer of hope that Entereg may eventually gain approval in POI,” writes Amsellern in an investor note today. “That said, we continue to believe that considerable risk surrounds the drug’s chances of approval, even though Entereg’s safety issues arose in a different patient population (i.e., chronic pain patients with opioid-induced bowel dysfunction, or OBD). Our concern mainly reflects the FDA’s high caution level on the safety front, particularly in non-life-threatening indications.”

“The Entereg POI studies didn’t reveal any serious safety issues (cardiac, neoplasms, or other). Additionally, in its last approvable letter, the FDA asked for a risk management plan in the POI setting, which we take to mean that the agency wants to ensure that Entereg is used only in the hospital, and suggests that the agency is open to allowing Entereg on the market for POI even in light of the safety issues that emerged in OBD.

“That said, the agency asked for the risk management plan prior to seeing the 12-month data from study 014, which raised even more safety questions (i.e., the six-month data that the agency saw uncovered cardiac issues, but the 12-month data uncovered an imbalance in the incidence of neoplasms). Therefore, we continue to view a positive panel outcome as high risk.”