GLFD's Gliadel sNDA non-approvable

Guilford (GLFD) received a non-approvable letter from the FDA for an sNDA for its Gliadel wafer to treat newly diagnosed malignant glioma. According to GLFD, the letter said the company's Phase III trial to support the sNDA did not show statistical significance on the primary endpoint of overall survival. GLFD and FDA used different statistical analyses of the Phase III data. FDA used the protocol-specified statistical analysis, a logrank test, that showed the difference in median survival between Gliadel and placebo was not statistically significant (p=0.078). GLFD said that an alternative analysis -- stratifying randomization results according to country -- yields a statistically significant result (p=0.027). FDA previously said that the protocol indicated that patients should be randomized by center, not country. ...