RE:RE:Once again... This is it
I think a huge part will come down to how good an FDA consultant they have. They are usually ex-FDA staff who know the ins and out. That consultant should be the ones guiding any application wording to enhance success.
There are so many interesting ways to present data. In addition to all the other comments, I like that they can say the following
- if a patient is CR at 90 days then has a 50% chance of staying CR till 450 days. That means the patient gets clarity quickly vs doing a whole year of instillations and then relapsing as with most of the other drugs.
I hope that they present well and the FDA reviewer has the insight to realize how different this is from all the whack a mole (repeatedly hitting the cancer to the point that seem CR but not really).