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Thursday, 08/17/2017 11:28:51 AM

Thursday, August 17, 2017 11:28:51 AM

Post# of 12606
The FDA charges approx 2 million dollars for the application fee for a new drug. That's just to file the application. That does not cover the pre-clinical testing, trials etc. Because the FDA approved the buprenorphine implant developed by Titan Pharma and because naltroxone implants have some deaths associated with their use, the data in their effectiveness hasnt been really studied etc, the fda will require extensive trials and also require studies comparing naltroxone implants to buprenorphine implant and other treatments. It's extremely costly and really no different than what they would have gone through with bicx101 which leads me to believe the reasons they gave for abandoning bicx101 wasnt the real story
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