GREY:IPHAF - Post by User
Comment by
WASKERWISKon Jul 13, 2010 8:18pm
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Post# 17267081
RE: All the speculation
RE: All the speculationWell obviously FDA isn’t going to communicate the outstanding issues to ISA (who is not the applicant) if it hasn’t communicated them to Lux (who is the actual applicant). Plus if ISA is saying that Lux is awaiting the action letter to determine what the issues are then ISA (who would otherwise have passed it on) can’t know either. Also, for what its worth, the biorunup guy (https://www.biorunup.com/665/isa-to-update) says he spoke to Aspeslet and she told him ISA has not been provided with any additional details on the issues.
So safe to say the ISA doesn’t know either (officially anyway; I am sure both ISA and Lux have some idea and maybe a pretty good idea)