wanaB: Say you are the WanaVax Corporation, in the business of developing a DNA vaccine. Pre-clinical studies come first, run on a series of animal models and usually concluding with primate testing. The amounts of DNA required for pre-clinical testing are minute, perhaps enough for thirty mice, 30 rabbits and 15 chimps. Assuming some favorable data you apply to the FDA for an IND. In Phase I testing the number of human subjects is small. Say on the order of 20-50 participants. If the vaccine shows promise you move on to Phase II. A larger study, but still not the quantities of synDNA that will move the money barometer. Participants in Phase II will probably number around 100. If you make it into Phase III testing the number of participants increases, but it would not exceed 1000-1500 in all probability. So from pre-clinical through Phase III you would only need to obtain enough syndDNA for a few thousand vaccines at most. That is not a large quantity of plasmid. Certainly not enough to generate sufficient profit for the DNA producer. The payoff comes after a full FDA approval. Then you see the demand in the Millions for a vaccine with worldwide application. But it takes 8-10 years from pre-clinical to market, and more importantly it takes hundreds of millions of dollars.
So I reitterate my concerns about the actual market for synDNA over the next 5 years. Even if CYGX were to convince multiple DNA vaccine makers to utilize synDNA, the potential market will continue to be rather low until a vaccine gains approval. Of the DNA vaccine makers out there today only Vical seems poised to release a vaccine in the next 3 years, and they are not a potential customer. CYGX has to find a way to survive 5-8 more years for the potential payoffs that comes with approved vaccines. You've seen the synDNA sales number so far. Not even in the hundreds of thousands yet. The small numbers correspond to pre-clinical and Phase I utilization. Any substantial orders are 5 years away, at best.
The question is, how does CYGX survive that long?
