AI
Wednesday, December 09, 2009 12:03:46 PM
You have your FDA steps out of order.
Among other things, An NDA comes after Phase III and is the final step before FDA review and approval.
As you can see from the chart below, NNVC testing is in the infant stages.
Normally, it takes 5 - 8 years for final approval. Being that this is new technology, I expect it to take longer, just because the FDA is very cautious with new technology. And the fact that the treatment can be considered only a temporary cure, because after treatment, it is possible to be re-infected with the virus, as no antibodies are produced. Could be a big political problem when dealing with the FDA.
Among other things, An NDA comes after Phase III and is the final step before FDA review and approval.
As you can see from the chart below, NNVC testing is in the infant stages.
Normally, it takes 5 - 8 years for final approval. Being that this is new technology, I expect it to take longer, just because the FDA is very cautious with new technology. And the fact that the treatment can be considered only a temporary cure, because after treatment, it is possible to be re-infected with the virus, as no antibodies are produced. Could be a big political problem when dealing with the FDA.
Deeds, not creeds.
