Symbol: OTC: LLBO
Additional information can be obtained at:
Worldwide Stock Transfer, LLC.
One University Plaza • Suite 505 • Hackensack, NJ 07601
Phone: (201) 820-2008, Fax: (201) 820-2010 , Email: email@example.com
The Company’s product, the iTBra™ (formerly the First Warning System™), is in the process of preparing for a 510(k) submission to the FDA. If a 510(k) is approved, commercialization of the the iTBra™ could continue to be pursued. However, there can be no assurance that the FDA will approve the Company’s submission. There is a possibility that the FDA could reject the technology and the claims concerning the capabilities of the iTBra™. The claims to be included in the submission are expected to cover the iTBra™’s process and ability to identify breast tissue abnormalities, which may indicate cancerous or precancerous conditions.
The FDA could require the Company to conduct the testing of additional patients to validate the capabilities and claims of the iTBra™. Should additional patient testing be required, additional financing resources could, and most likely would, be necessary. There is no assurance that the Company could acquire the funding required to conduct additional patient testing.
Should the FDA clear the iTBra™‘s claims and technology as included in the 510(k) submission, there can be no assurance that the targeted markets, physicians and their patients, will adopt the process in sufficient quantities to create a commercially profitable venture, hence, impacting the companies potential future value.