questions re phase 3 trial, page-3

I hadn't noticed Mr Dogs post before you had replied and thanks for the answer.

Andrew I have a question regarding the trial and the extra 25 people requested.

With such a addition ( 5% ) of trial number were they getting specific patients with a specific heart or other condition into the trial ? Those extra 25 were recruited withing 30 days so it almost seemed like the oncologists had them lined up or people really wanted to be part of the trial in the hope they might randomly get the "good" treatment? Were these extra 25 a special group ( all women, all men, all heart conditions? ) or just more of the same to bolster the overall stats to ensure there was a large enough subset of a minor group to be statistically significant to possibly cover all teh market intrican on its own is approved for?

When the FDA adds the extra 25 do you do your original data and then do a addendum or do you wait till it is all done to do the stats and then do the subset for the FDA on the extra 25?

Just wondering as non of us yelled and screamed when we learnt the extra 25 people due to the fast recruitment but with possibly a very long survival time and extra treatments in effect our timeline has been extended?


Last one - does anyone have any idea of what % treatments don't use Introcean as 1st or 2nd line? Is there a test that shows particular CRC are better treated with other 1st and 2nd line ?