- 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…
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