Friday, August 22, 2014 7:44:32 PM
Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna
This is basically the bridge study that will also be done for DengueCide. Again, soon our state-of-the-art 5kg cGMP Pilot Plant will make it possible to advance with all these drugs!
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