Now recruiting for BREEZE (Tret UTHR) study

[sugarland]

Some Monday morning good news for once. Second milestone payment made 👍

[lakers]

clinicaltrials.gov/ct2/history/NCT03950739?A=4&B=5&C=Side-by-Side#StudyPageTop

Changes (Side-by-Side) for Study: NCT03950739
Compare v3 to v4September 26, 2019 (v4) -- October 23, 2019 (v5)

Assigned Interventions:
Drug: Treprostinil Inhalation Powder
Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)

Other Names:
TreT

Added:

United States, Georgia
Emory University Hospital
[Recruiting]
Atlanta, Georgia, United States, 30322
Contact: Jane Gillespie, RN 404-712-8204 [e-mail]
Principal Investigator: Micah Fisher, MD

United States, Texas
Houston Methodist
[Not yet recruiting]
Houston, Texas, United States, 77030
Contact: Jennifer Lee 713-363-7537

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE)
clinicaltrials.gov/ct2/show/NCT03950739

The “Applicable Funding Conditions” section in the Credit Facility #3 Schedule in the Original Credit Agreement is hereby deleted and replaced in its entirety with the following:
“Applicable Funding Conditions: means the following:
(a) (x) Agent has received evidence satisfactory to it, in its discretion, that United Therapeutics has received positive clinical data on the Phase 1b BREEZE trial and (y) Agent has received evidence satisfactory to it (in its discretion) that United Therapeutics definitively intends promptly to file or has filed Treprostinil Technosphere for approval by Food and Drug Administration of the United States of America for the treatment of Pulmonary Arterial Hypertension;

(c) (x) Agent has received evidence satisfactory to it (in its discretion) that Borrower has received the full amount of all Milestone Payments (as defined in the United Therapeutics License as of the Closing Date) under the United Therapeutics License and (y) immediately prior to and after giving effect to the funding of the Credit Extension under this Credit Facility #3, Borrower is not in breach or violation (nor has United Therapeutics asserted any such breach or violation by Borrower) of the United Therapeutics License Agreement and United Therapeutics shall not have delivered any termination notice pursuant to Section 12.3 of the United Therapeutics License; and