Thursday, March 19, 2015 12:33:37 PM
Thanks for coming back on the board.
I wanted to ask you a bit more about the most meaningful Direct patient to date, Allan Butler. More specifically around the fact that Allan Butler's Stage IV pancreatic cancer shrank enough to qualify for surgically removal.
I understand that because the cancer was surgically removed, it is almost impossible to apply the traditional RECIST criteria against it.
What I would like to understand is the following:
1. Has this occurred before in the past? Other treatments have "shrunk" the tumor sufficiently that existing treatments which were not viable all of sudden are once again possible.
2. How has the FDA dealt with situations like this in the past? It is difficult for me to believe that scenarios like this has not occurred with Chemo or Radiation like therapies.
3. Is it logical to automatically increase the OS benefit for a patient once a previously unavailable treatment is automatically applied?
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