Re: Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial

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BearDownAZ

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Re: Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial

in response to

Re: Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial

SanFrancisco99

posted on Feb 23, 2017 10:12AM

The news release stated "Resverlogix intends to file an official Investigative New Drug (IND) application and proceed with the planned Phase 2a clinical trial in 2017."

We've been told at recent presentations that they planned to file the IND in Q1 2017 and that the trial would launch early 2017/Q1 2017. Although the sentence above does not negate these prior statements, my initial reaction is that the IND filing and trial launch is going to be delayed until Q2 if not later.

I'm also curious why they have to do another PK trial even though they did the New Zealand PK trial last year.

"In light of guidance received from the FDA, the Phase 2a study design will be separated in two parts. Part A will involve a single-dose pharmacokinetic (PK) study in eight patients receiving hemodialysis. The PK results from Part A will influence the dose selection for Part B."