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Re: Schnauzer1 post# 1638

Wednesday, 05/18/2016 5:34:09 AM

Wednesday, May 18, 2016 5:34:09 AM

Post# of 2296
Eravacycline is one of the most efficient antibiotics currently ready for P3 testing! See the published data from TTPH comparing activity against all the "bad bugs". So why is TTPH at a near 52 week low? Simple: the P3 team were too aggressive with testing protocol with the objective of winning the preferred drug status on all UTI infections. 3 day IV and remainder on pill formulation as a treatment protocol would have won top pick since every hospital wants to move patients out of inpatient care as soon as possible; IV treatment is big drag on achieving that objective for UTI.

So where are we at with new trial? TTPH will not risk failure again, so the P3 trials are all designed for overkill!! These test will kill the bad bug within 10% of efficiency of comparator. So rather than once a day IV they will do twice a day IV, thereby getting more drug into the blood! Accordingly, given the proven power of eravacycline's effect on bad bugs it's clear the design of P3 is to use sledge hammer for a finishing hammer's job, solely to ensure passage of P3. Rightfully so however, time for nuisanced differentiation of eravacycline's performance ability over comparators can happen later. FDA just wants this drug to pass the G**** Test!