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Thursday, April 03, 2014 2:16:04 AM
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govorchin said...
NCI rules state the facility where the trials take place have one day to notify the sponsor if a "cure" is suspected.
Questions I am trying to answer include:
1) Does it matter if the trial is Phase 1? Phase 1/2? Phase 2?
2) Once the sponsor is notified, what action is the "sponsor" expected to take.
3) Does this "suspected cure" status mean anything to the FDA when you are talking about a previously incurable fatal disease or condition? If so, what?
TIA
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