OncoSec Medical Inc (ONCSQ)

[hschlauch]

I think you are exactly right Titan. ONCS obviously has confidence to proceed with a phase 2 AA trial design that would theoretically support a NDA filing, with the stipulation of a future phase 3 confirmation trial.

However, the current phase 2 combination metastatic melanoma trial has Breakthrough Therapy written all over it, assuming data are as good as I think they will be. If they receive BT designation based on current trial data, it is even possible that a phase 3 confirmation trial wouldn't be necessary.

In any case, they appear to be very confident in the current phase 2 metastatic melanoma trial results. I think they are indeed elevating the relative percentages of PD-1 and CTLA-4-expressing TIL in predicted non-responders. If the patients are reaching that magic 30% threshold in TIL, then ONCS will be converting folks into responders. This is a very significant unmet need in metastatic melanoma. There are a majority who will not respond to checkpoint inhibitors alone or in combination, and among those who do respond, about 75%-90% of them are partial responders, which means there is still measurable residual disease. Those partial responders would, therefore, by definition become "refractory".