The FDA and other regulators around the world have been overwhelmed with applications to conduct COVID-related trials. Each application has to be assessed, as quickly as humanly possible, but it still takes time.
It is obvious from Noxopharm's announcement on 1 April that the Hudson Institute had analysed Idronoxil-C (aka Veyonda or NOX66), rather than Idronoxil itself, when it discovered that the drug (in the lab) inhibited the cytokines implicated in COVID-19 respiratory distress. It remains to be seen whether this mechanism of action is replicated in humans.
Noxopharm has long known that inhibition of ENOX2 by Veyonda did not explain some of the beneficial results (such as abscopal responses) achieved by the drug, and it was only recently that the Hudson Institute discovered another aspect of its mechanism of action - one that appears suited to COVID treatment.
Veyonda has proven in the LuPIN and DARRT trials that it is completely safe to use, so the authorities have nothing to lose if they give emergency approval for Veyonda to be used to treat seriously-ill COVID patients.
It has been just over two weeks since the Noxopharm announcement. In that interval the company has had to write a comprehensive trial protocol, one that would have required extensive consultation with Intensive Care experts, for instance. It would have made urgent submissions to the FDA and others; made sure it had drug ready to be shipped around the world; and made arrangements for more to be manufactured.
Noxopharm will be ready to ship Veyonda immediately approval is granted. Physicians, especially those consulted during the protocol design, will know how best to use the drug. Any response should be quick.
If Veyonda proves to be effective, it will turn a lethal illness into something like the flu. What a wonderful result that would be for the world!
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