News and research before you hear from CNBC and others. Claim your free 1-week trial of StreetInsider Premium here. The success of Lexaria’s HYPER-H21-2 human clinical study, the results of which were announced in the first week of September 2021, laid the groundwork for NDAChris’ proprietary DehydraTECH(TM) processed CBD Bunka, the company’s CEO, referred to the results as “statistically significant,” ultimately beginning the IND application process with the FDALexaria has since received a positive full written response from the FDA on its DehydraTECH-CBD, accepting the company’s proposal to pursue the 505(b)(2) NDA regulatory pathway, as a result. of the FDA’s favorable response, Lexaria expects to be on track to submit its full IND application, 6-9 months earlier than if the FDA had required modifications to Lexaria’s current work plan for IND, and its management is confident of maintaining the current trajectory. could enable the company to reach $1 billion a year in the hypertension market, even making it one of the most effective registered pharmaceutical treatments for hypertension and in the world
The first week of September 2021, Lexaria Bioscience (NASDAQ: LEXX) announced its most recent results, at that time, from its HYPER-H21-2 human clinical study on the overall efficacy of its proprietary DehydraTECH(TM) processed CBD on blood pressure. The success of the 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”), calling the results ” statistically significant” (https://cnw.fm/X9wKM).
The success of multiple human studies investigating DehydraTECH-CBD for hypertension led Lexaria to formally announce the process of submitting an Investigational New Drug (“IND”) application to the Food and Drug Administration (“FDA”) of the United States to list DehydraTECH-CBD as a…
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