Errata - FDA Clinical Briefing Document

ODAC May 9, 2007

Mifamurtide (IDM Pharma, Inc)

 

 

1. Page 23, replace in its entirety paragraph 4 which reads

 “Results were not provided for the formally planned final analysis at 167 DFS events.  An analysis was performed after more than 220 events based on the available data as of 7/10/2003.  An integrated analysis based on the time of the 167th DFS event is not statistically significant.  It is not clear whether the Type I error rate was controlled at a two-sided 0.05 level.  If the timing of the final analysis was influenced by the results of the previous analyses, the Type I error rate will be impacted.”

 

with the following paragraph:

 “A final analysis was not conducted at the timing pre-specified in the original protocol (3.9 years accrual with two years follow-up). From this timing and assumptions made in sizing the trial, it can be inferred that 167 DFS events would have occurred for the final analysis.  Applicant’s analysis was performed after more than 220 events based on the available data as of July 10, 2003.  It is not clear whether the Type I error rate was controlled at a two-sided 0.05 level.  If the timing of the final analysis was influenced by the results of the previous analyses, the Type I error rate will be impacted.  Note that integrated analyses performed by both the Applicant and the FDA based on information that would have been available at the time of the 167^th DFS event are not statistically significant (nominal p-values of 0.078 and 0.11, respectively).”

 

 

 

2. Page 7, line 5, Section A.4. “Regulatory Background”, delete the date of the second entry, “November 1991” and replace with the date “March 1993.”