@Bazsa - agree with your sentiments put in the other place.As...

@Bazsa - agree with your sentiments put in the other place.

As the founder of Mesoblast, Silviu is directly incentivised to see the thing he has built succeed. In this way we can trust him to ruthlessly prioritise his own interests, which are also inherently the interests of Mesoblast and its shareholders.

As individual investors we will never be permitted into the inner sanctum, and as such, our understanding of the constraints under which decisions are made at the company, will never be a complete one. Granted, it is easy enough to pass commentary on observable company performance and capital management, but its much harder to form a well reasoned view without emotion, that considers all of the known constraints in place, all of the options on the table and the various minutiae considered by management prior to an outcome emerging in the public domain.

Most investors intuitively understand that upon exchanging capital for shares in a company, on one hand they gain some ownership and at the same time both delegate responsibility to the board for governance and strategy, and to executive management for operational decision making. We effectively place our trust in those running the company to make the best possible decisions on the available data, in our collective interest.

It is my belief that Silviu will ultimately be vindicated for his perseverance with the regulator, and that we have already started to see the signs of this. There are many factors here but one just has to look at the FDAs reported suggestion post type C meeting, that upon “further consideration” they believe the existing data supports an approval in the paediatric cohort and that the company should resubmit.

While we should acknowledge that there were problems with the commercial potency assay which led to the last CRL, we should also acknowledge that the company brings to the table a significant scientific capability that under Silviu’s leadership, was able to solve for these problems in an apparently satisfactory way. To be clear, this is just one aspect that represents the immense value of the thing we have invested in. Meso is not some one trick pony with licensed IP and a “professional” CEO that wouldn’t have the faintest about the underpinnings of the products they are hawking, but a founder led scientific venture capable of solving incredibly hard problems, that is in the process of transforming into a commercial one. It is this set of features that mean Mesoblast shares some fundamental characteristics with other successful founder led enterprises, particularly those who persevered and succeeded despite all odds, while being forced to endure varied shrieking criticisms from “the market” over the years.

It should be clear to all and sundry at FDA that Mesoblast are not going away, and that both their capability as an organisation and the backing they have from leading specialists across indications cements this. Shining a light into the regulatory darkness by bringing industry into the conversation has proven to be a winning strategy when engaging with the regulator, not just for Meso. There is nothing like supportive attention from peers which serves to remind the regulator that they are supposed to make risk based determinations in favour of patients in need, not against them. Fear of scorn from ones peers is a powerful force, one that is capable of supplanting even the forces of grey corruption that often see bureaucrats transit through plumbing in the regulators basement to the expectant orifice of a pharmaceutical giant, in order to claim the rewards of sycophancy.

It’s just possible, despite whatever the share price does, and regardless of gnashing and angst from some, that we are on the cusp of greatness. Easy enough to lose sight of that.