Nanotechnology Now

Our NanoNews Digest Sponsors



Heifer International

Wikipedia Affiliate Button


android tablet pc

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

UT Arlington researchers develop transparent nanoscintillators for radiation detection for medical safety and homeland security September 29th, 2014

Iranian Scientists Determine Grain Size, Minimize Time of Nanocomposite Synthesis September 29th, 2014

Nanoparticles Used to Improve Quality of Bone Cement September 29th, 2014

'Pixel' engineered electronics have growth potential: Rice, Oak Ridge, Vanderbilt, Penn scientists lead creation of atom-scale semiconducting composites September 29th, 2014

Govt.-Legislation/Regulation/Funding/Policy

UT Arlington researchers develop transparent nanoscintillators for radiation detection for medical safety and homeland security September 29th, 2014

'Pixel' engineered electronics have growth potential: Rice, Oak Ridge, Vanderbilt, Penn scientists lead creation of atom-scale semiconducting composites September 29th, 2014

World's smallest reference material is big plus for nanotechnology September 25th, 2014

Solar cell compound probed under pressure September 25th, 2014

Nanomedicine

Nanoparticles Used to Improve Quality of Bone Cement September 29th, 2014

Teijin Aramidís carbon nanotube fibers awarded with Paul Schlack prize: New generation super fibers bring wave of innovations to fiber market September 25th, 2014

Nanotubes help healing hearts keep the beat: Rice University, Texas Childrenís Hospital patch for defects enhances electrical connections between cells September 23rd, 2014

Immune system is key ally in cyberwar against cancer: Rice University study yields new two-step strategy for weakening cancer September 23rd, 2014

Announcements

UT Arlington researchers develop transparent nanoscintillators for radiation detection for medical safety and homeland security September 29th, 2014

Iranian Scientists Determine Grain Size, Minimize Time of Nanocomposite Synthesis September 29th, 2014

Nanoparticles Used to Improve Quality of Bone Cement September 29th, 2014

'Pixel' engineered electronics have growth potential: Rice, Oak Ridge, Vanderbilt, Penn scientists lead creation of atom-scale semiconducting composites September 29th, 2014

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 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE