ADCOM Meeting

[CKTC]

https://www.fda.gov/advisory-committees ... -materials

Once the Event Materials are posted, hopefully, today, the two PDF files everyone will want to look at are:
• FDA Briefing Document
• Final Questions
Pay special attention to the Final Questions. You can expect to see a few Discussion Questions, which will be the focus of the ADCOM meeting. More important will be the Vote question. This is the question that ADCOM gets to vote on at the end of the meeting. The wording of this question can provide hints about the agency’s position on the application. I have even seen cases where the ADCOM is not even asked to vote.

[jayfish101]

Great post! My read is that there are a lot of negative comments about proof of efficacy.