My take from inside the USA, watching the recent goings on, is that nobody truly knows where this new regime is taking us. There is a lot of push back against traditional medicine at the highest level - vaccines especially. At the same time, there is also a large effort to promote 'natural' medicine, under which stem cells and MSCs would fall. Getting rid of additives to water, drinking unpasteurized milk would also fall into this 'natural' regime, according to them.
As you all are very aware, there has been a culling of long term experts within the broader Health and Human Services agency, which includes from the CDC and FDA. A lot of these people were sympathetic to MSCs, or otherwise truly believed that the status quo of approving medicines and treatments has to be changed. But agreement on one broad area hasn't been enough for some of those career people to retain their jobs, as the new political leadership has largely asked for ironclad agreement and for agency leaders to fall in line. The result of all those machinations is that many of the high level positions remain unfilled, and some are being filled by individuals who objectively would be considered less qualified, but who might have more malleable and less dogmatic views. You can call some of them eager beavers who see the opportunity to enhance a resume. I say some, because it is clearly not all.
How will this affect Mesoblast is all that we should care about. I think it is more likely a negative in the short term, but neutral to positive in the long term. SI and team spent the last 24 or so months cultivating relationships at the FDA that enabled them to avoid doing another trial, and even got the FDA to issue their own press release announcing the approval of Ryoncil. That was no small feat. Many, but not all, of the people that formed that core decision making group are no longer at the agency. All decisions takes a large number of people to get to yes, from junior analysts to senior directors. When there is so much turnover and change in direction, even those that remain takes a wait and see approach before moving forward, especially if their immediate superior who provided direction has left, or is new. That means delays for us. Once the regime is in place however, it should be positive as hopefully MSCs falls into the group of treatments that will get priority reviews.. I don't think anyone would hope for approvals on poor data. Instead we should hope that skeptics of the science will give deference to the company.
One final point on this. Administrations last for 4 years. It is unlikely that the agency leaderships lasts for 4 years. In any event, the direction of the agency could easily change in 4 years or less. Currently there is a blowback against MRNA technology - the same technology that mainly saved our asses during COVID. When faced with realities of governing, people make different decisions. So we never quite know for how long this current regime will take this approach. The arc of science is much longer than the arc of parliamentary politics.
All these developments bears watching as the short term implications could be important.
That's the view from the US, my view anyway.
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