No. What they've been doing is pre-clinical research, not subject to FDA approval. From this point on, if we say that pre-clinical research was succesful, then there are two choices:
1) Proceed directly towards marketing with a "cure" product. In this case they would have to engage the FDA for Phase I, II and III clinical trials to prove safety and efficacy. For instance, if CYGS completes development of the telomere renewal vector then this would be the road.
2) License the technology to other companies to form a complete "cure" package. In this case the other companies, depending on the deal, would be responsible for FDA approval of the total package. For instance, CYGS has expressed their strategy of licensing the ssDNA delivery vector to companies owning antisense molecules. Often, in these cases, the other company would be responsible for achieving FDA approval on the total antisense package. The licensor could get upfront money, milestone money as interim stages were achieved, royalties, revenues for their component of the package or any combination of the above.
Hope this helps, if its not clear I could dig up an example or two.
Graham |
