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Posted On: 06/03/2020 1:12:54 AM
Post# of 151873

Re: nmbr1stckpckr #36382
EINDs take time, effort, and attention. The CYDY team seems to have a much bigger plate than their stomach can digest. Let's see if they can finish the trials easier if they have one less ball in the air.
Also, reading NP's tea leaves, he seems to say that FDA thinks that EINDs make enrollment harder. That used to be the case until they changed the rules a couple years ago (2018?) so that EIND's could only be given for patients that would not qualify for a trial. Is the FDA guy that NP talked to working from an outdated impression of the way things used to work? Did the new rule not solve the old problem? Was NP misreading what the FDA told him? Am I misreading what NP said?
Also, reading NP's tea leaves, he seems to say that FDA thinks that EINDs make enrollment harder. That used to be the case until they changed the rules a couple years ago (2018?) so that EIND's could only be given for patients that would not qualify for a trial. Is the FDA guy that NP talked to working from an outdated impression of the way things used to work? Did the new rule not solve the old problem? Was NP misreading what the FDA told him? Am I misreading what NP said?


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