Vincristine Sulfate Liposomes Injection New Drug Application

 

Oncology Drug Advisory Committee meeting: December 1, 2004

 

 

FDA Briefing Document Errata Sheet

 

On page 4, third paragraph, second sentence, the 3 should be changed to 2.

 

On page 4, third paragraph, third sentence, the 3 should be changed to 2.

 

On page 7, section 2.3.1.2, the 8th line, 74 should be changed to 73.

 

On page 15, in the first Reviewer’s Comment: replace this sentence, “The protocol did not stipulate that responses had to be confirmed.” with the following “The first version of the protocol did not stipulate that responses had to be confirmed; however, later versions did.”

 

On page 24, third paragraph under Efficacy Analyses, please delete the first sentence of that paragraph.

 

On page 24, third paragraph under Efficacy Analyses, in the fifth sentence change the 10 to 13.