OK, here's what I've found via Chat GPT' very hard to find much...

OK, here's what I've found via Chat GPT' very hard to find much via Google.

In general, a new drug is unlikely to be approved as a monotherapy if it has only been tested in combination with other drugs during clinical trials. Regulatory agencies like the FDA (Food and Drug Administration) or EMA (European Medicines Agency) typically require that a drug be evaluated in clinical trials both as a monotherapy and in combination with other treatments to understand its safety and efficacy profile in different settings.
Here’s why: Efficacy and Safety: To approve a drug as a monotherapy, regulators need to see data demonstrating that the drug alone is effective and safe for treating the intended condition. If the drug has only been tested in combination with other treatments, there may be insufficient data on how it performs by itself.
Dosage and Administration: The optimal dosage and administration schedule for the drug as a monotherapy might differ from those used in combination with other drugs. Data from combination trials may not fully address these aspects.
Regulatory Standards: Regulations typically require a comprehensive set of data to approve a drug for any use. This includes showing that the drug provides a clinical benefit as a stand-alone treatment.However, there are exceptions and variations depending on the drug's mechanism of action, the disease being treated, and existing treatment options. In some cases, a drug might be approved for combination therapy first, with a subsequent application for monotherapy based on further evidence. But initially, strong evidence of efficacy and safety as a monotherapy is usually necessary for approval for that indication.

So it appears to me that even though the cash burn at IMU seems high, our management is doing all in it's power to get CF33 to the bedside either as a monotherapy 'or' in combination with current SoC, to put it simply IMU needed to raise a shiteload to try to get to the end goal.
I can only say YF and LC must truly believe there's something special here.
GLTAH