Wednesday, August 16, 2017 9:53:52 PM
Naltrexone Implant (Biocorrx) Acquired North American rights to new implant formulations and Prodetoxone study data in 2016*
• 3 month formula has been used in other countries as unlicensed product for several years with 6 month version just developed.
• Data acquired for Prodetoxone, which is the ONLY naltrexone implant approved by a regulatory body (Russia for 15+ years)
• Prodetoxone been through multiple trials conducted at St. Petersburg Scientific-Research Center of Addictions and Psychopharmacology, Pavlov Medical University, in conjunction with the University of Pennsylvania, Department of Psychiatry, Philadelphia, USA
• Plans to seek FDA 505(b)(2) regulatory approval in US
*Very similar formulas and protocols were purchased along with the North American rights to certain non-public Prodetoxone study data which is expected to assist in a more efficient FDA approval pathway.
***End Slide***
The more I read the smarter their move sounds. Seems like they got sidetracked with BICX101 and this setback might be a blessing in disguise. In hindsight getting implant approved might be faster to any IND than the path we were on. Next few weeks should be interesting.
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