Nanotechnology Now







Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > Stellar Biotechnologies Announces pre-IDE Meeting with FDA

Abstract:
Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) announces the completion of a pre-Investigational Device Exemption (pre-IDE) meeting with the U.S. Food and Drug Administration's (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health to discuss Stellar's proposed anti-KLH assay currently in development.

Stellar Biotechnologies Announces pre-IDE Meeting with FDA

Port Hueneme, CA | Posted on May 10th, 2011

The outcome of this consultation with the FDA assisted Stellar to identify and define its strategy to complete the clinical development and regulatory pathway for the anti-KLH in vitro diagnostic device. The FDA encouraged Stellar to consider additional clinical investigation plans that may distinguish the clinical correlation of the assay results with measures of patient immune response.

Stellar is committed to pursuing this unmet medical need to make this diagnostic tool available to clinicians as quickly as possible, and will work to complete the development and regulatory activities identified during this meeting with the Agency.

####

About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) (www.StellarBiotechnologies.com) is a world leader in sustainable manufacturing of pharmaceutical grade immune carrier proteins (ICP), particularly with regard to the present most important pharmaceutical protein in this class, KLH (Keyhole Limpet Hemocyanin). This evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source.

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company's securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of these releases.

For more information, please click here

Contacts:
Darrell Brookstein
Executive VP

Copyright © Stellar Biotechnologies, Inc.

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Scientific breakthrough in rechargeable batteries: Researchers from Singapore and Québec Team Up to Develop Next-Generation Materials to Power Electronic Devices and Electric Vehicles February 28th, 2015

First detailed microscopy evidence of bacteria at the lower size limit of life: Berkeley Lab research provides comprehensive description of ultra-small bacteria February 28th, 2015

Leti to Offer Updates on Silicon Photonics Successes at OFC in LA February 27th, 2015

Moving molecule writes letters: Caging of molecules allows investigation of equilibrium thermodynamics February 27th, 2015

Govt.-Legislation/Regulation/Funding/Policy

First detailed microscopy evidence of bacteria at the lower size limit of life: Berkeley Lab research provides comprehensive description of ultra-small bacteria February 28th, 2015

Warming up the world of superconductors: Clusters of aluminum metal atoms become superconductive at surprisingly high temperatures February 25th, 2015

SUNY Poly CNSE Researchers and Corporate Partners to Present Forty Papers at Globally Recognized Lithography Conference: SUNY Poly CNSE Research Group Awarded Both ‘Best Research Paper’ and ‘Best Research Poster’ at SPIE Advanced Lithography 2015 forum February 25th, 2015

European roadmap for graphene science and technology published February 25th, 2015

Nanomedicine

Untangling DNA with a droplet of water, a pipet and a polymer: With the 'rolling droplet technique,' a DNA-injected water droplet rolls like a ball over a platelet, sticking the DNA to the plate surface February 27th, 2015

Graphene shows potential as novel anti-cancer therapeutic strategy: University of Manchester scientists have used graphene to target and neutralise cancer stem cells while not harming other cells February 26th, 2015

Cutting-edge technology optimizes cancer therapy with nanomedicine drug combinations: UCLA bioengineers develop platform that offers personalized approach to treatment February 24th, 2015

Optical nanoantennas set the stage for a NEMS lab-on-a-chip revolution February 24th, 2015

Announcements

Scientific breakthrough in rechargeable batteries: Researchers from Singapore and Québec Team Up to Develop Next-Generation Materials to Power Electronic Devices and Electric Vehicles February 28th, 2015

First detailed microscopy evidence of bacteria at the lower size limit of life: Berkeley Lab research provides comprehensive description of ultra-small bacteria February 28th, 2015

Leti to Offer Updates on Silicon Photonics Successes at OFC in LA February 27th, 2015

Moving molecule writes letters: Caging of molecules allows investigation of equilibrium thermodynamics February 27th, 2015

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More










ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2015 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE