SHC sunshine heart, inc.

Going to be about 6 years before this could possibly be brought...

  1. 339 Posts.
    Going to be about 6 years before this could possibly be brought to market. To designing the trial, fda approval of design, getting sites approved and up to speed, enrolling patients at hopefully a modest pace, following them for 6 months (if fda agrees to this), then analyzing data, submitting data, fda shenanigans while analyzing the data themselves, then adcom perhaps, and then a decision perhaps a year after submittal of nda (or pma, whatever it isb called). Hopefully a positive decision and approval.
    All that being said, might as well keep this on the backburner, not really follow it. Maybe some more down here, but even then can this go down even more?
    I certainly don't have the discipline to just forget about it for weeks and weeks, let alone years and years...do you?
 
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