As Lucky said, all medical applications will require FDA approvals. I'm quite sure that is why KBLB currently has them on the "back burner". Because revenues would be so far in the future, KBLB first needs to establish other sources of revenue (Monster Silk, pure spider silk, other high tech textiles, etc.) to enable it to develop the medical applications without incurring the severe dilution it would otherwise take and, probably even more importantly, to give it market stability.
The whole development time period when a company as no products on the market is much riskier for it than when it has sources of revenue. In a severe market downturn, for example, many companies that were making excellent progress and showing every indication of future success nevertheless go under just because raising money for continuing development becomes too difficult when cash gets scarce. Because Monster Silk is so close to being market ready for KBLB this period of dependence on investment money is drawing to a close (and it has the Calm Seas agreement which should supply ample cash and time to get it to a positive cash flow point.
It should be noted that the major reason that KBLB has such excellent short/intermediate term financial potential is that most of its products (especially the earlier ones)
1. will not require any FDA approval
2. nor approval for release of genetically modified organisms into the environment
3. nor any food safety testing
4. PLUS manufacturing facilities already exist (just switch out the worms in a standard silk manufacturing facility).
5. and the production technology (silkworms) has been used and developed for over 5,000 years.
This very unusual combination is what gives KBLB such a high potential for very rapid growth and expansion.
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