Hi @MelbourneBoy, my view on the point you raise is quite...

Hi @MelbourneBoy,

my view on the point you raise is quite simple, but does require analysis.

I looked but really don't see any evidence of anything that IMO would 'smack of diversion', however your point that similar 'activity' has not always warranted an update is a good opening observation.

So then, why not notify us of the results at the time? To me, the publication of the journal commentary ' Prospective randomized controlled trial of the safety and feasibility of a novel mesenchymal precursor cell therapy in hypoplastic left heart syndrome' on October 1, 2023 (see link) wasn't in any way market sensitive, and therefore wasn't anything required to be disclosed. Money didn't change hands on the article's publication AFAIK. It would have been maybe 'nice to know' (from a holder's POV), but that's not the analytically proper viewpoint for a discussion on disclosure, as I see it.

The 'right' viewpoint for MSB (IMO) is to ask itself instead what it was going to do about it i.e. do about the results being talked about in the publication, and then ask itself when it was obliged to acquaint the market of what it had decided to do. Why is that more important? Because that point in time is when the company itself, by its own unequivocal actions, commits its hard-earned i.e. the financial and other resources, stops thinking about things as options and turns internal speculation into action.

Now, keep in mind that the company couldn't do anything that relied on the publication of the results/ outcomes and the trial methodology until...well, the actual publication!. I know, it sounds a little silly to say that, but that's the way it goes - it means that a peer-reviewed research article isn't a 'peer-reviewed research article' until it's published as such.

So, when the company made it's announcement this morning i.e. on 27 November 2023, that was a date by which the company had taken action - action to file for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) for Revascor in connection with HLHS. I find it easy then to see this point in time - only 1 month after the results were actually publicly published - as most likely the earliest that any application based on those results could have been filed with & accepted for lodging by the FDA, and therefore the earliest that it could have been notified to the market anyway.

I could be wrong, but I simply see it as business as usual.

Having said that, it's a wonderful additional prospect for use of rexlemestrocel-l, and may well attract a willingness to give early marketing approval from the FDA (because of the rarity of the condition under treatment) notwithstanding that key remaining production requirements are yet to be resolved for other indications and also remestemcel-l. @otherperspective's post this morning was a great read on these aspects. For me, the results scream 'regenerative' bioactivity, and the degree of consistency/ similarities with rexlemestrocel-l's hypothesised MOA in other indications can only IMO be supportive of an eventual FDA finding that increased LV systolic and diastolic volumes over 12 months compared with control is a good-enough surrogate for that regeneration.

All good stuff IMO.

Cheers,
Hope to see y'all in the morning.

.