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drkazmd65

10/02/14 10:23 AM

#100655 RE: daBoze #100647

I'm not insider enough to know the specifics to answer your questions completely daBoze.

I suspect that (at least in part) you have answered your own question.

The animals used and the cell culture assays used have relatively small mass (individually) and were tested out over a fairly long period of time - so the amount of 'Cide needed at any moment during the early preclinical stages was fairly low.

Small-scale syntheses (a few grams at a time) have been worked out for a long time (years) and no doubt are routine with well developed Standard Operating Proceedures and defined protocols. Chances are - they didn't need to make much at a time in order to do the work in front of them.

TOX is a different case - especially after the original ranging studies done last year let the company know exactly how much of the injectable Flucide they needed to get the job done.

I have previously (in my past research life) worked on some optimizations of biological systems for production of and assay of a fungal metabolic product. We had worked out some nicely standardized conditions for production of this compound (an animal hormone analog) in individual 200 ml containers - but when we tried to scale up to bigger containers (a few liters) we had to spend a good deal of time re-optimizing conditions again.

Things like surface/volume ratios, mixing speeds and fluid dynamics, ratios of catalysts (if needed) to reagents, temperature and many other conditions can change how processes work in unexpected ways when you try to change scale in a laboratory process.

So - the problems that NNVC has encountered in scaling up - while annoying to individual investors (myself included) in causing delays - should have been expected. Could the Company have headed them off better or overcome them more quickly? Don't know as I wasn't there - but my guess is - that's the basis of the reason why going to Kg scale syntheses have been problematic.