NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Not what I said. NNVC is not screwed if passage across the blood brain barrier occurs.

They will however have to show that there are no adverse effects over the time frame of clearance. Existing animal studies up to Max Feasible Dose showed no behavioral or cognitive effects. Suggestive of good results in Regulatory Tox, but not definitive.

And the concern from a timing standpoint is development of analytical methods of detection of FluCide in the various tissues of the body. The testing timeframes are not affected to my understanding - unless there is distribution to specific tissues that does not metabolize or excrete in a reasonable time frame. PEG studies I discussed about a year ago are strongly suggestive of both safety and a relatively short time frame for excretion by glomerular filtration through the kidneys. And these safe molecules are likely to have passed through the blood brain barrier as well based on their size (molecular weight).

And don't forget - as this is an injection, Cmax occurs effectively immediately, so there is no need to calculate the timeframe of Cmax with absorption experiments. Distribution, Metabolism (should be minimal) and Excretion are the only real things to test here for ADME in the PK studies.