Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) is a business that manufactures a wide range of pharmaceutical products. Its products help with the treatment of acute neuropsychiatric conditions.
They also serve as remarkable medication in supporting biodefence. It was today that the business guru outlined that it would soon commence its Phase 3 trial of Tonmya®*.
A close outlook
This company seeks to succeed on its quest to handle posttraumatic stress disorder (PTSD) in the most effective way. It exudes confidence that by the first quarter of the coming year it will have made significant steps forward.
An expert well conversant with the matter outlines that their latest Breakthrough Therapy offers them great guidance. This therapy was in line with the company’s Type B Clinical Guidance meeting. The Food and Drug Administration (FDA) attended the meeting providing insights on ways the company could enhance its manufacturing activities.
The company presented helpful data in the course of its meeting with the regulatory body. It started off by presenting interim analysis results. The data emanated from the original Phase 3 HONOR study.
An outlook into the future
The business giant says it has plans underway to incorporate a number of its latest design features in the study. The undertaking will involve putting in place several restrictions. It seeks to commence by putting up restrictions on the number of persons that enroll for the study.
The study only takes individuals struggling with PTSD. The screening time varies but in this case scenario it involves those experiencing index trauma. The associated screening time has to be nine years.
The Chief Executive Officer of the pharmaceutical company Seth Lederman commented in relation to this study’s innovative design features. The official asserts that they will help a great deal towards the advancement of Tonmya for PTSD.
Lederman opined, “Results from our Phase 3 HONOR study strengthened the design of the new Phase 3 study, which has been accepted by the FDA as a potential pivotal efficacy study to support NDA approval.”
The official discloses that they intend to make this particular trial a double-blind.