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I have watched as certain posters have tried to unpick the potency assay data….I look forward to hearing their groans when they realise the answer has been staring them in the face all along..but I refuse to assist competitors in their analysis"
Uhuh. I've struggled with this one too. You and I may be thinking about the same thing with the potency assay - I think you know I like re-reading a lot of MSB publications, earning call transcripts and announcements. I'd very much like to talk about it, of course, but I think you and I are sharing the same reaction to this situation i.e. when I can't see a good (and public) reason why someone would want/ need to know something in the kind of detailed interrogation that's been going on lately, I get very leery and clam up - and I just don't want to post my thoughts to anonymous readers/ posters on a public forum.
I know this may well sound a little selfish, stupid or just plain arrogant (or all 3) to genuine MSB holders (& so, I really do apologise to those holders), but I also don't want to inadvertently assist MSB's competitors (think Incyte, Novartis etc) - especially at this critical juncture. Note I'm not talking about the FDA here. Or some wannabe listing on ASX. MSB's real competitors have the money to do really scary things to protect their multi-$bn revenue streams. Think Lassman-type submissions etc.
But what I can do is post the stuff that our enemies really don't want to see, and that MSB may very well have been waiting until December 2022 for.
LIke these, from ASH#22, showing the vital difference between OR (the surrogate endpoint that ruxolitinib has relied on to get itself where it is today) and OS (the best possible clinical outcome for aGVHD patients):
and I've taken the liberty of highlighting the part Incyte and Novartis dont want to see:
Yes, it's not good when your flagship product continues to worsen patient condition significantly more even than glucocorticoid steroids on their own. I would think MSB would want to incorporate some comment on these results in the BLA resubmission. Might be worth the delay.
We're in a war, as I see it. In this analogy the prize is healthcare market share. And MSB's various enemies have a headstart & big chunks of the high ground between us and the goal. Why isn't the FDA an enemy? Well, the FDA as I see it is actually the battleground itself. It's procedures and process requirements, with all their ups and downs, are pitfalls and traps for the competing armies to navigate while moving across this landscape. Traps are everywhere - what seems like solid ground can fall away beneath our feet. Being sure of one's footing is often worth taking the time. And there are bottlenecks and choke points - and most importantly really rickety bridges - that just have to be crossed, otherwise it's a long way round. We're at one of those bridges right now IMO, and possibly the most important in the entire battlefield for MSB. I hope we've brought the right gear to get across.
Cheers
(20min delay)