Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-558

Hi @stanjupiter,

I'm overseas atm on business. Re the cost of therapy point, I know it's a bit of a dry biscuit for many. But one can learn a lot from studying insurance and risk assessment, IMO.

As I recall the limit of CEO Itescu's preparedness to foreshadow specific (or even likely) Ryoncil treatment pricing to the post-AGM group was his statement that US insurers have indicated to MSB their willingness to price by reference to the curative gene therapies. He said this, as I recall, in response to a rather brusque question from the floor about what the pricing was going to be & whether MSB would make enough out of it. So the word 'curative' which should not have been forgotten, was lost in the general shareholder interest in & response to the mention of $$$. Completely understandable.

But it was a critical point for me at the time & still is. For reference pls see these earlier posts:

A. Post #: 71317625 on the post-AGM Q&A; and
B. Post #: 73075474 on the single question raised at the Q&A Feb 29, 2024 Earnings Call; and
C: Post #: 73113420 as a summary of the key points from the two previous posts

To summarise your excellent posts above if I may: those who are ultimately & properly the most cynical in the Big Pharma end of our industry, as you correctly identify them i.e. the impassive actuaries of human life (US insurance life/ morbidity tables assessors) are required by their day jobs to see and pay for Ryoncil as comparable with similar products i.e. products producing similar outcomes.

And we can assume those same actuaries then also see the stats that show the rate of aGVHD progression to cGVHD i.e. they see those risks of mortality/ morbidity too - and yet are still willing to compare Ryoncil with the best curative gene therapy products then that must mean, by necessary implication, that they are viewing Ryoncil unemotionally as a curative product itself,

So then that arguably means the industry already sees Ryoncil - a mere allogeneic somatic cell therapy - as at least an equally validated solution (from their POV) to at least some of the risks of overall morbidity/ mortality outcomes of chronic disorders as any of the current SOC crop, including Rux and the gene therapies for that matter, IMO.

And they're willing to put their money - well, actually, everybodys money - where their mouth is.

All we need now is for that risked assessment to trickle through to the hind brains of the regulators at FDA.

Cheers
See you at the pub in November