The Company reported in April 2013 that the engineering design of its cGMP manufacturing plus laboratory facility is substantially complete.
The important and rate-determining step towards the start of any clinical program for FluCide is the construction of the production plant in Connecticut
o NNVC hired contractors and builders who build the framework at their own plants, then deliver to site in a modular fashion and then integrate on-site
o This ex-location production is both cost- and time- efficient and could be completed 5 months from start date
Lets be conservative and say that assembly begins on this month, July 2013. NNVC should have the plant ready by December2013!...ready and validated.
o The pilot plant will likely be ready to begin producing FluCide test batches by YE2013 or 1Q2014
Indication from NNVC - FDA meeting is: toxicology studies will continue in parallel with the construction of the manufacturing plants. Both will likely conclude at the same time by YE2013 allowing for production of drug materials for the seamless start of the clinical program in 2014.
Puffer indicated that to be conservative, human trials are likely to start Q3 2014. From my perspective, conservative is good.
In the NNVC RedChip video Dr. Seymour indicated NNVC is on a path, a track, Project Managers are steering, key activities on a timeline, to completion. That video, and the demeanor of Dr. Seymour fills many voids in the big picture. It was good.
The potential of catastrophic event(s) that could delay are always present but the Project Management group steering is a seasoned one. The plant will be physically complete by the end of 2013 and the steady climb will begin.
