Hi @Kerebrad,
I share your concerns about MSB's path to break-even. I too feel we can almost taste it.
But I really don't see what's being disclosed in the ASX communications with MSB shareholders & Earnings Call discussions as 'goalpost shifting', used in a perjorative sense.
I see it as adaptation. By MSB. And, to a lesser extent, by the FDA. That's what organisms do to survive, as you and I both know. And it's a good thing. Because without it we die.
That's also what I am taking from the Announcement references to 'collaborative' actions on the part of MSB and FDA right now. And I think we should all be aware that the FDA is not 1 voice - there are many references in Summaries of Actions on approval that disclose internal arguments & outright disagreements across divisions within FDA personnel, even within CBER itself.
That's why @Lopez keeps mentioning Dr Verdun's involvement IMO. To me, it's a huge blinking light on how far the FDA has gone & is going in its efforts to adapt itself.
And IMO this improved collaboration between MSB and FDA now has the very high likelihood IMO of producing a WIN/ WIN scenario, in paediatric SR-aGVHD and adult SR-aGVHD, out of what started as a worrying dispute resolution in 2020. We keep and improve our working relations with the FDA - whose apparoval we need elsewhere. We get our moat. We get cash flow from operations. They get to recast the resolution of the dispute as us having jumped over their highest hurdles. And so on.
All good, as I see things.
Cheers
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