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.
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.
Related News Press |
News and information
Simulating magnetization in a Heisenberg quantum spin chain April 5th, 2024
NRL charters Navy’s quantum inertial navigation path to reduce drift April 5th, 2024
Discovery points path to flash-like memory for storing qubits: Rice find could hasten development of nonvolatile quantum memory April 5th, 2024
Govt.-Legislation/Regulation/Funding/Policy
NRL charters Navy’s quantum inertial navigation path to reduce drift April 5th, 2024
Discovery points path to flash-like memory for storing qubits: Rice find could hasten development of nonvolatile quantum memory April 5th, 2024
Chemical reactions can scramble quantum information as well as black holes April 5th, 2024
Nanomedicine
New micromaterial releases nanoparticles that selectively destroy cancer cells April 5th, 2024
Good as gold - improving infectious disease testing with gold nanoparticles April 5th, 2024
Researchers develop artificial building blocks of life March 8th, 2024
Announcements
NRL charters Navy’s quantum inertial navigation path to reduce drift April 5th, 2024
Discovery points path to flash-like memory for storing qubits: Rice find could hasten development of nonvolatile quantum memory April 5th, 2024
The latest news from around the world, FREE | ||
Premium Products | ||
Only the news you want to read!
Learn More |
||
Full-service, expert consulting
Learn More |
||