Some time back I mentioned that scale-up of the specific nano-micelle material manufacture could be giving them a problem.
In reading the letter to shareholders, I noted their discussion of that and classifying the scale up problem as having been anticipated, but remaining a bottleneck of sorts regardless.
I would advise based on my experience that this is rather typical. While I have been involved in sub micron fine particle handling, I have not been involved in its manufacture to rigid requirements I suspect NNVC desires.
This is one of the areas I think additional funds could help with. However, I would think it might not be a major critical path problem at the moment. I believe they have parallel paths going. One is to keep up the investigative process into basic efficacy testing with the other highly interested entities they describe, while the other is to pursue the manufacturing issues as cost effectively as they can at the moment.
This is probably the single biggest reason for any delays in toxicity testing and evaluation. Attempting to build a facility that manufactures a consistent superior nano-scale product without a known blueprint of how to do so in the best fashion is quite difficult. Ultra-fine materials have behaviors that can create significant equipment selection and operation issues. Many of the issues are seldom initially apparent. Primary agglomeration from static and van der waals forces is only one issue that comes to mind.
While I think this is a problem for them, I am actually not that concerned. The biggest concern is how it impacts their production quantity and quality for the next more demanding testing phases. It is vitally important they don’t drastically change their process, even if it takes long to create the needed batches. We had to manufacture a material for a about 8 months in a lab scale process to make enough to run one quick process opeation test. It took so long we had to be concerned about deterioration of the initial material by the time we completed enough to fill our test reaction chamber.
This is vitally important so that the efficacy, which is likely tied to the product quality and consistency, is not impaired by any such possible changes in manufacture. I have seen material characteristics change rather remarkably after scale up to large batches.
From an ultimate production standpoint, when proven in humans, the technologies and material processing expertise that can then be brought to bear will be either knocking down their door or be much more easily afforded by them.
It is important to understand that specific nano-material manufacture is a relatively new process with specialized unit operations that are not widely known or developed by the chemical and materials process industries. In performing their scale-up trials, I hope they also keep a look out for patentable unit operations and manufacturing techniques as well.
