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Re: Rdunn88 post# 246237

Wednesday, 10/24/2018 2:26:09 PM

Wednesday, October 24, 2018 2:26:09 PM

Post# of 403091
The presumption on my end was that if given BTD and priority review, the guidance (given in an EOP 2 meeting) for a Phase 3 trial would not include overly burdensome requests so our potential partner would not need to wait on the results of that meeting before deciding whether to execute the partnership agreement.

"Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs."
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