NetworkNewsBreaks – Lexaria Bioscience Corp. (NA
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Posted On: 08/10/2022 5:15:20 PM
NetworkNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Receives Positive FDA Feedback Concerning Opening IND Program
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced its receipt of a positive full written response from the Food and Drug Administration (“FDA”) from its pre-Investigational New Drug (“Pre-IND”) meeting regarding DehydraTECH-CBD for the treatment of hypertension. According to the update, the FDA confirmed agreement with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway for its program. This is advantageous because the abbreviated pathway, as it is often described, typically enables a faster route to commercial approval than the traditional 505(b)(1) NDA pathway. “We are very pleased to have received comments from the FDA toward opening our IND program and we will be executing FDA-confirmed IND-enabling work immediately,” said John Docherty, president of Lexaria Bioscience Corp. “We were delighted that our proposals were very well received by the FDA and the feedback received will be very helpful in compiling and filing our IND application as the next major regulatory step we are focused on moving forward.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced its receipt of a positive full written response from the Food and Drug Administration (“FDA”) from its pre-Investigational New Drug (“Pre-IND”) meeting regarding DehydraTECH-CBD for the treatment of hypertension. According to the update, the FDA confirmed agreement with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway for its program. This is advantageous because the abbreviated pathway, as it is often described, typically enables a faster route to commercial approval than the traditional 505(b)(1) NDA pathway. “We are very pleased to have received comments from the FDA toward opening our IND program and we will be executing FDA-confirmed IND-enabling work immediately,” said John Docherty, president of Lexaria Bioscience Corp. “We were delighted that our proposals were very well received by the FDA and the feedback received will be very helpful in compiling and filing our IND application as the next major regulatory step we are focused on moving forward.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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