Book Online or Call 1-855-SAUSALITO

Sign In  |  Register  |  About Sausalito  |  Contact Us

Sausalito, CA
September 01, 2020 1:41pm
7-Day Forecast | Traffic
  • Search Hotels in Sausalito

  • CHECK-IN:
  • CHECK-OUT:
  • ROOMS:

Lexaria Bioscience Corp. (NASDAQ: LEXX) Delighted About Well-Received DehydraTECH-CBD Proposals by the FDA; Maintains Late 2022/Early 2023 Target For Complete IND Application

  • Lexaria’s successful HYPER-H21-2 human clinical study, whose results were announced in the first week of September 2021, laid the groundwork for the company’s patented DehydraTECH(TM)-processed CBD NDA
  • Chris Bunka, the company’s CEO, referred to the results as “statistically significant,” ultimately kickstarting the IND application process with the FDA
  • Lexaria has since received a full written positive response from the FDA on its DehydraTECH-CBD, agreeing to the company’s proposal to pursue the 505(b)(2) NDA regulatory pathway
  • As a result of the favorable FDA response, Lexaria expects to remain on track to file its full IND application, 6-9 months sooner than if the FDA had required modifications in Lexaria’s current IND-enabling work plan, and Its management is confident that maintaining the current trajectory could allow the company to achieve $1 billion per year in the hypertension market, even making it one of the most effective registered pharmaceutical treatments for hypertension in the world

In the first week of September 2021, Lexaria Bioscience (NASDAQ: LEXX) announced its most recent results, at the time, from its HYPER-H21-2 human clinical study on the overall effectiveness of its patented DehydraTECH(TM)-processed CBD on blood pressure. The successful study would play an integral role in the company’s eventual New Drug Application (“NDA”), with Chris Bunka, the company’s Chief Executive Officer (“CEO”), terming the results as “statistically significant” (https://cnw.fm/X9wKM).

The success of multiple human studies investigating DehydraTECH-CBD for hypertension prompted Lexaria to formally announce the process of an Investigational New Drug (“IND”) application filing with the United States Food and Drug Administration (“FDA”) to list DehydraTECH-CBD as a…

Read More>>

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CBDWire

CBDWire (CBDW) is a specialized information provider focused on (1) reporting CBD-related news and updates, (2) releasing CBDNewsBreaks crafted to keep investors abreast of the latest and greatest in the CBD market, (3) refining and enhancing corporate press releases, (4) delivering end-to-end distribution and social media services to client-partners and (5) constructing effective corporate communication solutions based on the unique requirements of CBD companies. CBDW is exclusively positioned in the burgeoning CBD sector with a proven team of journalists and researchers working to deliver high quality content to an expansive target audience of investors, consumers and industry news outlets. Our dissemination network of over 5,000 downstream distribution points allows us to deliver unparalleled reach, visibility and recognition to companies operating in both cannabidiol and the wider cannabis space. CBDWire (CBDW) is where CBD news, content and information converge.

To receive instant SMS alerts, text CBDWire to 21000 (U.S. Mobile Phones Only)

For more information please visit https://www.CBDWire.com

Please see full terms of use and disclaimers on the CBDWire website applicable to all content provided by CBDW, wherever published or re-published: https://CBDWire.com/Disclaimer

Do you have questions or are you interested in working with CNW? Ask Our Editor

CBDWire (CBDW)
Denver, Colorado
www.CBDWire.com
303.498.7722 Office
Editor@CBDWire.com

CBDWire is part of the InvestorBrandNetwork.

Data & News supplied by www.cloudquote.io
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.
 
 
Photos copyright by Jay Graham Photographer
Copyright © 2010-2020 Sausalito.com & California Media Partners, LLC. All rights reserved.