...and once you produce something even slightly different to Par/Bene's iPPS you need to conduct FULL clinical trials...from the start... and we all know how many years that journey is. Something even that's even a teeny tiny different (nth degree) will invoke this arduous process as no one knows the clinical repercussions... the FDA will not accept this without the full due process.
In the quite...ok, VERY, rare case you get an exact match..they would STILL need to go through the ENTIRE clinical process as we quite simply aren't approved yet!! Then we talk about Patent infringement!
Ann: iPPS Demonstrates Multiple DMOAD Signals in Phase 2 Study, page-206
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