As Mozz so eloquently and enthusiastically shares with us, the science and efficacy of ipps is without question imo. The simple fact is the extraordinary sums of money required to achieve approval is mind boggling, and together with PAR managements inability to estimate with any remote degree of accuracy what these costs might be, well who would touch us at this stage….until we have more certainty around process and cost we will remain where we are…just need to keep ticking those interim boxes and hang in there for now. Hopefully/surely the science will eventually win out (though a very small part of me has always worried fda may be under a little pressure from those opioid producing companies…but that couldnt happen in the states could it?)…
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