In order to determine if NNVC's NV-387 IND package is good enough for FDA, NNVC needs to actually submit it to them. It remains puzzling why NNVC goes so slowly with FDA and clinical trials, other than that Diwan is a cowardly and greedy control freak (loves the gravy train, afraid to try because that means the drugs might fail and the whole gig would be up), or maybe they are still working out some manufacturing issues, or there is some other unknown reason why it has taken them so long to apply for an IND and take one of their many 'cides into trials in the US after all these years. If I recall correctly, the last communication was that NNVC was going to have a pre-IND meeting, and think about submitting an IND for NV-387 by the end of 2025. They are hoping their NV-387 that targets HSPG binding viral antigens will be an oral, broad spectrum antiviral, good against multiple (respiratory) viruses like RSV, CoV, and IAV (fluA). It's WAY WAY overdue for them to plan and get into a human trial. They move SO SLOWLY that it is bewildering. That said, they did seem to show that NV-387 was safe in humans with their Phase I India trial, with NO dose limiting toxicity, and this data will surely be part of their IND submission to FDA, along with their planned Phase II trial against multiple respiratory viruses. People can and will continue to shout fraud here, without presenting any solid evidence of said fraud. Hard to know what to believe. The truth will come out some day. That day keeps getting closer and closer as NNVC finally does a trial to see if these nanomedicines work, or they run out of money, or something. It will be interesting to see if they can get a partner to fund and run the trial.
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