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Tuesday, January 28, 2014 10:14:31 AM
Will you please check that I have understood this correctly.
TOX studies involve
(a) Single dose acute toxicity studies - These studies need to be done for four weeks in at least three animal species, one being a non-rodent. NNVC has done this study in mice only, two other animals still need to be tested. What is your opinion about issues arising in other animals.
(b)High dose tox studies - This is already complete in mice. Does NNVC have to study this in other animals?
Then in phase 1 toxicity on humans will be checked. You think that the chances of toxicity in humans is low given the evidence so far.
The drug has shown very high efficacy in mice. You think that the chances of efficacy in humans is very high given the evidence so far.
Am I missing something?
Seeker
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