MSB (ASX) How low can we go?

Originally posted by Martin37: ↑

I can see from your arguments that you do not have a good grasp on the regulatory, reimbursement and marketing environment in the US.

Regulation
The first reason that we don't compare Rex-L to Cortisone Injections is simply because this is not a requirement from the FDA. The FDA does not require manufacturers to compare their investigational therapies (drugs) to a comparator therapy (drug). I believe some of the key reasons for this is because: it may hinder drug development/innovation through adding 'unnecessary costs' (and in some cases prohibitive costs for smaller manufacturers) to complete the clinical trials process; there may not be an appropriate/ideal comparator; these 'head to head' studies can be done post approval... At the end of the day the FDA is charged with the responsibility to determine whether there is a clinical need for an investigational product and whether the benefit to risk equation is favourable. There is no regulatory requirement to gain approval that says investigational drug X need to be more effective than existing competitor drug Y; investigational drug X just needs to provide adequate evidence to demonstrate a favourable benefit to risk profile to gain approval.

Don't get me wrong I do agree that in some instances this lack of 'head to head' data may make it frustrating for physicians to decide how a new treatment compares to existing therapies and how to integrate it 'fit it in' to their prescribing arsenal.

Reimbursement
In broad strokes, the US health system is quite different to the Australian health system. Australia leans towards a universal government funded system (free hospital visits for public patients in public hospitals, bulk-billing doctors...) while the US leans towards a privatised system where patients (or their employers...) purchase health insurance to cover their medical expenses.

In general the price of therapies (pharmaceuticals) is higher in the US compared to other OECD countries. This is good from the viewpoint of a drug manufacturer.

Ramifications for Rex-L once approved vs Cortisone Injections for CLBP in the US:

1. It will be the insurers that will pick up the full tab for Rex-L (or most of the tab if a modest co-pay applied) for the majority of patients as most US citizens have health insurance. So it is likely in the majority of patients that cost will not be a barrier to accessing Rex-L. Also the cost of manufacturing Rex-L likely to further reduce as we can achieve scale of manufacture (i.e. allogenic - not autologous).
2. In the real world Rex-L most likely positioned after conservative management failed (e.g. NSAIDS, physio...) and before Cortisone Injections if trial results similar. Why? The current evidence is lacking (listen to recent investor presentation) of a reliable and meaningful reduction in pain benefit of Cortisone Injections in CLBP, often having a small to no benefit on average - and having too many injection in the same target area can instead cause nearby tissue issues, hence why it's recommended to limit the number of Cortisone Injections in an area to no more that 3 to 4 in a year. Chronic Lower Back Pain is "CHRONIC" and Cortisone Injections not meant to be a long term treatment option. We heard from the presentation that the reason Cortisone Injections are prescribed is largely because there are no other reasonable options and patients are screaming for something to get them out of pain and returning to life as usual. It is not that evidence is driving its usage.
3. The target market initiating Rex-L will be Pain and Orthopedic Physicians (not your local doctor) - and they would see every day that Steroid Injections have limited to no (or fleeting) effect in treating CLBP and would be aware of the variable outcomes following surgery. This leaves a real window for us (after conservative failed and before more surgery). I truly believe Rex-L is what they have been waiting for if we can repeat trail results (i.e. durable relief in pain, day procedure with minimal disruption of patients lives, no negative disruption to surrounding tissues, potential to eliminate the need for costly surgery...

In short, will be a BLOCKBUSTER without the need to run a head to head against Cortisone Injection.

Expand

I specifically mentioned that comparing to pred (or to HA control) was for the target market, not for FDA approval. So glad we agree on that point.

Reimbursement is different in the states, of course. Many people with CLBP will have insurance. But most people have insurance through their work, and many with CLBP are unable to work. Almost all insurance has massive deductibles as well (well in the thousands), so the point still stands.

All I'm saying is at this stage, even if they got FDA approval tomorrow, they would need to replicate these results with another robust study before they could expect people to shell out big bucks for this therapy (in any significant amount). Assuming an approval should all of a sudden justify a $45 price tag is outrageous ($30 billion company?).

Purely IMO.

Speculate all you want, though

What's lovely about this is we will know who is right eventually! And tbh id rather be wrong

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