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Re: KMBJN post# 79662

Wednesday, 02/05/2014 4:50:41 PM

Wednesday, February 05, 2014 4:50:41 PM

Post# of 146228
From the Jan 27th PR we know that the cGMP plant is not quite finished yet, and then testing and validation needs to be done. I would say quite a while yet before production begins. The schedule released called for phase 1 trial to begin in 2015.

"The Company reports that its project for enabling clinical scale drug product cGMP capability at the Shelton facility is now nearing completion of construction. After construction is complete, the facility, and particularly the cGMP Clean Room Suites will undergo facility testing and validation to ascertain that the facility satisfies the requirements. After validation, the Company plans to occupy the new facility while keeping the current facility active to minimize impact on the multiple nanoviricides® drug development projects. The Company intends to first start production of FluCide in the cGMP section, set up appropriate cGMP operation for this production, produce multiple batches of FluCide under cGMP conditions, and demonstrate equivalence of the batches produced, in preparation for human clinical trials."

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