Replies to post #100491 on NanoViricides Inc. (NNVC)

[KMBJN]

Agree that in a perfect world, NNVC could anticipate the problem areas / bottlenecks, and work to solve those problems / relieve those bottlenecks to allow the work to proceed faster.

It's hard to remember that the things they are doing *have never been done before* so they have to invent solutions along the way.

Do you think there is some consultant out there who knows how to tag or detect nanoviricides in tissue, or to control the process for self-assembling amphiphilic nanomicelles in large batches? Perhaps.

Myself, I'm a little disappointed that their collaborators, who actually test their nanovicides, seem to be so slow. I think that if they had the personnel in-house to do the testing, it would go much quicker.

Always a balance to outsourcing vs. in-house work in terms of saving costs, saving time, and protecting IP.

[robi-1-kenobi]

They actually had more than a year. This should have been clear after their Pre IND meeting with the FDA in April 2012.

Good project managers look to their long lead time items and those tasks on the critical path to make sure they don't get caught like this.

These tasks can still delay timelines if the technical challenges are particularly difficult. In this case there could be background PEG levels difficult to separate from the drug signal detection. And the ligands are similar to naturally occurring sialic acids so difficult to measure as well.

But there are technical options around such difficulties that could have been explored and answered much quicker than the 2.5 years passed since Pre IND - such as fluorescent markers in place of a portion of the ligands.

This development effort needs to happen quickly now to fall within their 12-18mo timeline for preclinical studies. My understanding from the 10K is that this is included in that timeframe and is not anticipated to extend it. We will see.