It is a certainty that there will not be an approved drug from NNVC available for next spring's flu season.
The following steps have to take place:
1. The necessary toxicity studies have to be completed and the IND must be approved by the FDA.
2. Phase I trials have to be carried out. They have to be successful (no significant toxicity in humans).
3. The FDA has to approve Phase II or combined Phase II/III trials.
4. NNVC must raise enough money to carry out these far more expensive trials. That means more dilution of shares.
5. The trials have to actually cure the flu in human beings. We all hope this will be the case, but nobody knows whether it will work as of now.
6. The FDA has to approve the drug.
My most optimistic timeline is that it will be 2 years before NNVC has any drug curing any human disease, with 3 years being more likely. That assumes that the basic technology is sound, and will actually cure viral diseases in humans.
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