NanoViricides Inc. (NNVC)

[arvitar]

CMC work done for anything but the exact molecular structure being pursued for use in clinical trials would be irrelevant to the FDA, and hence it wouldn't be done. Well, it could be done, but it would be a complete waste of time and money.

In NNVC's case, that means CMC work would have to be done for the general polymer backbone (which I assume you mean by "micelle") with the specific ligand attached.

The fact that each half of this combination can be manufactured and studied separately doesn't negate the requirement that all the CMC work also has to be done for the exact molecular structure to be used in humans.

The fact that the same micelle can be used with different ligands doesn't negate this requirement. It's the combination that is seeking approval, not the micelle without the ligand. Hence the FDA will only be concerned about the CMC work for the micelle+ligand, and not just one or the other.

The same would be true for any regulatory agency in any country.