FDA ODAC Meeting Material discussion analysis, page-64

I'm afraid that there is simply too much for me to summarise, but the article is very comprehensive as to what occurred with the six cases. They summarise the trials the drugs went through, how many members of ODAC met and when, and the questions posed to the members of the committee. ODAC then summarise their decision (in these cases, the "no" decision) and why. They then summarise how, upon further application, the FDA approves the drug. (In the instance of the CysView kit, the new application altered for the detection of lesions to "the FDA approved the product for the detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, somewhat limiting the indication statement")

Some of their reasons were headlined, but further summarised for each applicable case as:

- Study design
- Favorable beneft-risk not established
- Clinical relevance (endpoint of follow-up detection did not meet statistical signifcance)
- Favorable beneft-risk not established
- Need for additional studies