san diego - full summation of meeting, page-27

The IND was in the midst of electronic transfer at the SD meeting. The FDA has the 30 day window to comment. You have Thanksgiving and Xmas Holidays. None of us knows the FDAs motivations or where they place us in the queue. I know the principals at SD meant that the institutions performing trials and the therapeutic is ready to go. Everything is set except the FDA. The FDA are not my favorite people. I believe they do more harm than good. My view is that they are a monolithic, bureaucratic, righteous, self serving entity.