Replies to post #75154 on NanoViricides Inc. (NNVC)

[JG36]

I'll stand by what I said. And I'm pretty sure the FDA will too.

[ZincFinger]

Your basic point is very valid. However a more accurate way to state it is that, once the first drug in a platform is approved, the safety of the platform technology is established and issues related to the safety of the platform will not have to be addressed in subsequent tria

A good example is SGMO"s In Vivo Protein Replacement platform.

The main safety consideration with these drugs is the safety of the zinc fingers that insert the sequence into the genome. But the exact same location is used for all applications and therefore exactly the same zinc fingers. So once the drug is approved, the safety of the zinc fingers is not a concern for subsequent applications. Because the ZFs were the main safety concern that's a huge advantage for subsequent drugs. The rest of the drugs are inherently very safe because they are gene sequence to produce EXACTLY the normal protein whose lack is the sole and root cause of the conditions to be addressed (monogenic disorders).

Similarly with nanoviricides the main safety concern is the basic part of the structure (and what happens as it is broken down and excreted). Because the receptors are very similar to natural receptors, they are unlikely to cause problems. So, again, the first drug establishes the safety of the basic platform and the part that is different for subsequent drugs is the part that is inherently very unlikely to cause problems.

Subsequent drugs will not only be much faster to make, they will also have considerably less risk in clinical trials.

[BonelessCat]

That's absolutely what will happen. One only has to look at flu vaccines, which can be developed, tested and marketed within 6 to 9 months and at clinical sites in time for the next flu season. The platform is proven, though each flu strain has to be tested for safety in humans. Still, the whole process takes about a year provided a safe vaccine is doable.

After FluCide, and only for the next few indications, NNVC will only need to show safety in a quick Phase 1. After that, straight to Phase 3. Eventually, if safety profile is consistent for every viricide, straight to Phase 3. We already see this for drugs that are reconfigured and retasked for new diseases:sTraight to Phase 2/3a.