COVID IND

I missed some nuances from Noxopharm’s announcement that the “FDA allows Veyonda® Pre-IND Submission for COVID-19”

Let’s see what was said:

• Noxopharm (ASX:NOX) today announces that on advice from the U.S. Food and Drug Administration (FDA), the Company has lodged a pre-Investigational New Drug (pre-IND) submission for a clinical trial of Veyonda® in patients with SARS-CoV-2 (COVID-19) infection.

• • In other words, the FDA recommended that Noxopharm submit a COVID pre-IND application.  This must be a good sign.

• The submission is based on a response to a package submitted to the FDA summarising the rationale for conducting a clinical trial with an inhibitor of cGAS-STING signalling.

• • Noxopharm must have submitted a package to the FDA; and the FDA must have been impressed because it then recommended that NOX apply for an IND through the pre-IND process.

• The urgency of the situation means that if the pre-IND is evaluated positively by the FDA, it can be converted into a fully expedited IND approval. The conversion of a pre-IND into a full IND is a new option offered to high priority COVID-submissions and reduces the time and complexity of the FDA review process significantly.

• • The FDA has published extensive guidance documents which set out the COVID IND process, including comment that submissions would be accelerated based on the completeness of their content.

It sounds like Noxopharm has ticked all the boxes so far.