NanoViricides Inc. (NNVC)

[changes_iv]

Data, Upcoming Trials, and Optimism

The company also believes that by moving away from a vaccine-type approach, treatment can also become far more cost efficient. In an extended trial, FluCide was shown to be 1,500 times more effective than TamiFlu in a lethal animal model.

Dr. Seymour said that further trials of FluCide will take place in Australia because the Australian government reimburses 45 percent of research and development expenses, and also favorable conditions for certifying their drug manufacturing facilities.

A Phase 1 and 2a trial is planned to commence in the fall of 2014, after construction work to expand a leased research lab in Shelton, Connecticut is completed. Dr. Seymour said the timeline on the trials is short: a Phase 1/2a trial involving 24 patients would take about four to six weeks, followed by a Phase 2b trial with 100 patients, which would take about another month, and then a Phase 3 trial with a sample size of about 500 patients would take two more months.

The company plans to seek approval abroad first. However, as Seymour noted, the recent “Pandemic and All-Hazards Preparedness Reauthorization Act of 2012” bill could mean that FluCide’s approval in Australia could lead to marketization in the United States in as little as two years.

“We could have material available in the U.S. for the 2014-2015 flu season.” Dr. Seymour said. “Definitely a year later, we would have a hell of a lot more.”

source: http://www.onemedplace.com/blog/archives/13522

"Given the potential magnitude of what they are doing, a quarter or 2 difference on the timeline is really immaterial. Except of course the potential impact on Weedie's party planning activities." ~ weedhopper

Either way we are just going to do very well! Once that cGMP Pilot Plant is humming, is going to be humming for a long time!!!