Well of course some investors are dismayed about the switchback...

Well of course some investors are dismayed about the switchback SP. Understandable, but they needn't be.

I know this is a bit repetitive but it doesn't hurt morale to be reminded of a few things. Also, publicity is bringing new observers here and they might appreciate a bit of orientation in this truly puzzling story.

1. Approval to market Ryoncil for aGvHD is a rent bet for later this year.
That alone justifies a SP considerably greater than the present. If you don't have to sell, and you don't sell, good profit is near guaranteed.
This powerful sentiment is personal and you must DYOR.

2. aGvHD is just one of more than a few applications for Ryoncil. Investigations are already underway, not always by MSB, for label extensions. If successful, a bonus on top of item 1.

3. Ryoncil for Covid-19 related ARDS.

From the April 5 announcement: -

Mesoblast Chief Medical Officer Dr Fred Grossman said: “The FDA clearance provides a pathway in the United
States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both
expanded access compassionate use and in a planned randomized controlled trial.”

Meaning two lines of enquiry

a) expanded access compassionate use.

The extremely ill patients to test on are available in hundreds, if not thousands.
Their doctors and nurses will be more than keen to try something as respectable as Ryoncil, well and truly proven safe.
Ryoncil is already available in US as part of aGvHD treatment program.

We need the patients but we won't need much patience. The Chinese MSC study (n7) saw improvement in days. The physicians will be administering Ryoncil as soon as they can get it. Maybe already. Results, good or bad, will be seen in less than a week. They should be reported immediately because if it works then the sooner it is used widely the more lives will be saved.

This is only an observational process. No placebo control group. All patients involved will get the goods. But the ICU units will soon and easily know the difference if it works.

This will not be the controlled study correctly required by FDA for formal approval but if the results are as good as the tiny Chinese one then the pressure from families and politicians will be irresistible.

b) the planned randomised controlled trial.

These usually take quite some time to agree the protocols, get FDA input and approval, organise study sites, supply the material.
I am very confident that in this case everything will be done properly and without shortcuts (it must, otherwise the results cannot be accepted for analysis) but with utmost speed.
To start with, this is well practiced ground for MSB.
And the endpoint is pretty stark. Dead or alive. And in days. The statisticians won't spend long on this one. Don't need them. Nothing like the years of follow up for CHF and CLBP.

If the observations from a) and b) are not favourable then we will have a disappointment to worry about. But even then, by Q4 this year Ryoncil sales will bring sanity back. And that's even without CHF and CLBP.

AND don't forget posts from several of us telling that Covid ARDS is only a part, perhaps a small part, of the crippling and fatal lung conditions caused by ubiquitously present threats.

Relax.