MSB Trading 2021 - paradigm shift, page-7715

Overall, I am okay with the company's communications--as a purely practical matter, the path they have chosen just doesn't allow them to do much more, as you note. They are entirely captive to the FDA and its decisions and timelines (and it's clear the FDA won't be rushed--regardless of dying kids or COVID patients).

The biggest problem I have with the company is the sheer bloody-minded narrowness of their vision in obtaining approvals for their products.

Other countries have patients suffering from COVID-induced ARDS. Kids dying from AGVHD. People suffering from heart attacks. People addicted to opioids due to chronic lower back pain.

Temcell and Japan have shown that there are other governments and agencies that see the utility of the products that MSB is selling.

Yet we never hear ANYTHING from MSB about plans beyond the US and the FDA (save for the possibility of a joint US-EU trial with Grunenthal for CLBP...where even THAT is tied to the bloody US and the FDA!).

What's the vision for expansion and seeking approvals beyond the US? To India? To China? To Japan, for Pete's sake? Is it only AFTER we get an FDA approval that company will even think about moving to other countries? We don't know, because the company never tells us anything about it. I would guess that's because it has no such plans.

Seems, though, that aggressive approaches to governments and relevant agencies in Brazil, India, Australia, the UK, the EU, etc., etc., on the strength of the COVID ARDS and AGVHD results have to be at least worth considering.

And if the company has good reasons why they aren't considering those approaches, then we shareholders have a right to hear about that.

I assume the company's thinking is that the FDA's approval is the gold standard, and that everything will follow from there...but what if the FDA continues to refuse to approve the products? What if the assays that MSB says "appear" reasonable to the FDA end up being deemed by it to NOT be reasonable or sufficient at all? $10 million in cash burnt, and no closer to obtaining approvals in any other countries and generating additional--and very necessary--income, let alone in the frickin' USA.

Seriously: we are an Aussie company, and not a single one of us has the slightest idea what the path to approval for any of our products is even in Australia. Worse yet, we have no idea if the company itself has the slightest idea, or even a germ of a plan.

That. Is. Insane.