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Foxwoods Man

05/24/17 12:48 PM

#11259 RE: morecheese #11258

Nope...the hold is not being lifted because:

the FDA stated: “We have completed the review of your April 19, 2017, submission and have concluded that removal of the clinical hold is not warranted since item 3 of the October 15, 2016 letter has not been resolved. In addition, we have identified new deficiencies in your April 19, 2017, submission.



This makes it also obvious that there is more to the hold than a pamphlet wording issue since there will be no more pamphlets handed out

The hold HAS to be lifted for the study to be completed otherwise the data obtained is useless without an approved study.