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Tuesday, 12/13/2016 6:13:07 PM

Tuesday, December 13, 2016 6:13:07 PM

Post# of 233195
Sorry I am windy tonight, but I have free time to share my thoughts. There is a definite Paradigm shift from safety to Efficacy when dealing with an Unmet Disease state. Take Hypertension for example, there are numerous choices out there that are safe and effective. If a new product came along with minimal efficacy differences and unknown long term safety parameters..then very slow adoption..even by the KOL's and Thought Leaders. However, in an unmet Disease state, the paradigm shifts towards efficacy and away from safety. Not that safety is not important, but we are dealing with lethal disease states, merely by the nature of the patient's condition. A Viral Load of .05 reduction vs. .07 along with the 300 to 30 "N" reduction should cue you in on the FDA's commitment to this UNMET DISEASE STATE!! Efficacy,Efficacy, Efficacy...I believe any surprises in safety after Seven various trials..One two years and running, along with viral load suppression should set up for a wonderful 2017!!
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