Bottom Line…. During any drug approval process, the FDA clearly differentiates single-agent vs combo therapies for any indication. It is well understood that single agents when used in combo generally improve efficacy overall. Right now, the FDA is interested in how we stack up against Keytruda & other "single" agents with regards to approval or not. And the CMS (Centers for Medicare & Medicaid Services in the US) & the FDA don't always see eye to eye. Just because the FDA medically approves a drug doesn't necessarily mean it gets approved for coverage by CMS. Due to high new drug costs, coverage can get restricted to only those entered in clinical trials. The harsh reality is that too many patients will go untreated, undertreated, or go broke while under treatment. The recently approved drug for Alzheimer's (Aduhelm) is a perfect example of the end-all powers of CMS.
CMS will have the final say, & it is they who often dictate a new drug's ultimate commercial success. I sense the FDA has been under increasingly more pressure to prioritize increased availability of more treatment options (particularly for unmet conditions), & I don't doubt the economic impact of a new drug has subtly worked its way into the approval-decision equation. In the end, there is only one reality when predicting the potential for a new drug's durable commercial success...it has to simply take into account both its clinical & economic value.
I'd say we are well positioned to be the next best single-agent option, not to mention its huge potential as a combo drug or add-on. There are very few limits with this ACT considering our tech's potential across multiple indications & the promising potential of our other patent-protected organometallics (i.e. using Ruthenium, Osmium, etc.). I sleep much better these days...