Get IPPS through FDA / TGA is the answer.
It's bull#hit the amount of time its taken for IPPS to get approval given the unmet need and the programs that they have had running. If you look back at some of the studies (and Im talking pre 2000) the evidence is clear. Yet hear we are 2021 taking about a 2024-25 registration.... No major AE's, great safety record and it works....
After the last PAR update their references to Aus / Europe has me thinking they are abandoning the "global" registration and looking to push AU / EU as US may take a little longer than PR first thought (IMO). The FDA seem content to stall because they can...
research reports and media, page-2001
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