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Re: govorchin post# 57892

Thursday, 04/03/2014 2:16:04 AM

Thursday, April 03, 2014 2:16:04 AM

Post# of 403102
@govorchin or BK or anyone who knows - I would like to do some more reading on this. Can you provide a link? Mr. Google has not been much help this time. wink. I am curious not only for CTIX drugs but also for other drug candidates.

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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