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Tuesday, August 21, 2018 11:12:48 AM
Efficacy with different cisplatin schedules: There is some evidence that most toxicities, including oral mucositis, are more severe with weekly cisplatin and there is compelling evidence that cisplatin every 3 weeks is more effective in treating HNC. Differences in treatment effectiveness of SOM in these groups is of great interest to FDA and, for god shakes TIAB, to ANY treating doctor.
Applicant also needs to address efficacy in subjects with HPV induced HNC vs subjects without HPV. HPV induced HNC is considered easier to treat and that may alter efficacy results in treatment of SOM.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
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