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April 16, 2018

Company	Drug/Device	Medical Condition	Status
Abbott	optical coherence tomography (OTC)	high-risk, complex coronary artery disease	Phase I trials initiated enrolling 3,650 subjects in North America, Europe and Asia
Translate Bio	MRT5005	first-in-human clinical trial in patients with cystic fibrosis	Phase I/II clearance given by the FDA
Adynxx Inc.	brivoligide (AYX1)	post-surgical pain	Phase II results announced
GTx, Inc.	enobosarm	post-menopausal stress urinary incontinence (SUI)	Phase II trials initiated enrolling 493 subjects at over 60 clinical trial centers across the U.S.
BiondVax Pharmaceuticals Ltd.	M-001	universal flu vaccine	Phase II trials initiated enrolling 9,630 subjects age 50 years and older across four-to-six countries over a period of two flu seasons
Therapix Ltd.	THX-110	adult subjects with Tourette syndrome	Phase IIa topline results announced
AbbVie	upadacitinib	moderate to severe Rheumatoid Arthritis	Phase III topline results announced evaluating 37 subjects
Stealth Biotherapeutics	elamipretide	Barth syndrome	Orphan Drug Designation granted
Clovis Oncology Inc.	Rubraca (rucaparib) tablets	adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy	FDA approval granted

Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

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