Saturday, June 25, 2016 5:40:31 PM
"I hope that this clarifies his remarks
The plant should be ready for occupancy in roughly a year or so
The tox studies should be done before that
We can go into humans in certain countries as soon as the tox studies are done and enough drug material is made in our laboratory to do the trials
The plant should be ready to produce necessary materials for human trials in the US in approximately 18 months
We will file for the IND after we occupy the plant and FDA approval for US trials will be contingent on getting three consistent batches produced in the new plant (Oct 2013?)
If everything goes according to plan, I feel that we will hit the 2013-2014 flu season in the US with our trials and with some luck, the 2012-2013 season outside the US (March/April 2013)
Remember that many of these issues are out of our control so giving exact dates is not possible
EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC"
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