I also wanted to elaborate on why I believe the DARRT-2 study will be more significant than the IONIC study in the short term. In my view it all comes down to FDA approval.
The DARRT-2 trial is a pivotal trial and should be enough for NOX to go to the FDA with to obtain approval via an expedited pathway since the cancer treated will be refractory to all other treatments i.e. an unmet condition with high rates of mortality. Of course it will be subject to a confirmatory post-marketing trial, but this will be a significant de-risking moment for the company with considerable upside.
The IONIC trial, if successful, has great potential in the mid-term, but not the short term in my opinion. BMS can lock in a treatment by purchasing the rights to license a treatment. Even if they did enter into a licensing agreement or agree to acquire the product, milestone payments will be contingent on meeting certain achievements, which will include obtaining FDA approval. In order for BMS to gain FDA approval for Veyonda they will need to run at least two adequate and well controlled studies. This will take quite some time unless NOX can prove these patients have unmet needs. I'm not sure whether being refractory to Opdivo is enough to meet this requirement.
I maintain my view that 2021 won't be very lucrative for NOX, but mid-2022 may very well be depending on clinical trial results.
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