Re: IND filing for Renal Trial

...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Dear Agoracom Family,

I want to thank all of you for your patience with us over the past 48 hours and apologize for what was admittedly a botched launch of our new site.

As you can see, we have reverted back to the previous version of the site while we address multiple forum functionality flaws that inexplicably made their way into the launch.

To this end:

1.We have identified 8 fundamental but easily fixable flaws that will be corrected in the coming week, so that you can continue to use the forums exactly as you've been accustomed to.

2.Additionally we will also be implementing a couple of design improvements to "tighten up" the look and feel of the forums.

Have a great Sunday, especially those of you like me that are celebrating Orthodox Easter ... As well as those of you who are also like me and mourning another Maple Leafs Game 7 exit ... Ugggh!

Sincerely,

George et al

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BearDownAZ

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Re: IND filing for Renal Trial

in response to

Re: IND filing for Renal Trial

tada

posted on Mar 21, 2017 06:26AM

Tada wrote "All of the phase II trials were EMA trials as the FDA never approved them on the cardio side."

According to ClinicalTrials.gov, the study locations for Phase 2 SUSTAIN were in South Africa and the study sites for Phase 2 ASSURE were in Argentina, Belgium, Brazil, Hungary, Netherlands, Poland, Russian Federation and Spain. Both SUSTAIN and ASSURE were sponsored by the Cleveland Clinic with Stephen Nicholls as the listed investigator. I did not start following Resverlogix until after ASSURE was already planned and launched, so I do not know if Resverlogix even attempted to include US study sites for SUSTAIN and ASSURE. Since SUSTAIN and ASSURE did not include US study sites, Resverlogix may not have needed to seek FDA approval.

Their first phase 2 trial, ASSERT, did include US Study sites since Orange County Research Center (Tustin, California, United States, 92780) is listed as the only study site location in the ASSERT ClinicalTrials.gov listing. Stephen Nicholls of Cleveland Clinic is listed as the trial investigator for ASSERT as well. Since ASSERT is a Phase 2 trial and California is in the US, I am assuming that the FDA must have "approved" this Phase 2 ASSERT trial.