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longusa

02/10/14 7:37 PM

#4292 RE: flipper44 #4291

You're right it is a possibility. I'm not sure it would be ASCO-worthy, though. The ASCO submission has me thinking systemic response seen. We'll see in June!

foxhound02

02/10/14 8:52 PM

#4297 RE: flipper44 #4291

I am very confident that every patient in the direct trial has multiple tumors. These patients are metastatic and in very advanced stages of disease progression and of course they will be measuring the response to the injected and other tumors. However, the slow period is typical of virtually all first in class drug trials. It is mostly for safety (and dose response in this case). Let me give you a hypothetical that is not out of the question. Imagine there was no slow period and you inject one patient per week. Now, at 5 weeks from injection the first patient's immune system goes into hyperdrive resulting in a massive immune response. Fever goes to 105, organ failure, septic shock, death. Now you have 4 more patients who were injected and heading for the same very nasty outcome. This is largely why FDA demands that there is a very slow uptake of patients for treatments with no history. Very standard procedure.