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Research / Clinical pharmacology / Food and Drug Administration / Pharmacology / United States Public Health Service / Investigational Device Exemption / Validation / Clinical research / Pharmaceutical industry / Pharmaceutical sciences


Nile J. Boldt, et al. v. Venaxis, Inc., et al. 15-CV[removed]Class Action Complaint for Violation of the Federal Securities Laws and Jury Demand
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Document Date: 2015-02-05 20:55:15

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File Size: 918,03 KB

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Company

Nasdaq Capital Market / VENAXIS INC. / Defendant Venaxis / /

Continent

Europe / /

Country

United States / /

Currency

USD / /

Event

Judicial Event / FDA Phase / Conference Call / Funding / /

IndustryTerm

clinical trial protocol / in-vitro diagnostic device / follow-up communications / predicate device / unnecessary radiologic imaging / interstate telephone communications / marketed devices / generation product / marketed device / /

MedicalCondition

abdominal pain / disease / acute appendicitis / appendicitis / /

MedicalTreatment

radiation / /

Organization

United States Securities and Exchange Commission / U.S. Food and Drug Administration / Class / FDA / FDA’s AI / United States Food and Drug Administration / /

Person

JEFFREY G. MCGONEGAL / Steve Lundy / STEPHEN T. LUNDY / /

Position

Chief Financial Officer / advisors / President and CEO / Chief Executive Officer / President / and a member of the Board of Directors / candidate / the APPY1 diagnostic test / general corporate purposes / /

Product

If a predicate device / APPY1 / If / APPY / /

ProvinceOrState

Colorado / /

Technology

radiation / artificial intelligence / clinical trial protocol / /

SocialTag