Ah yes, that new adult trial planned for patients refractory to both steroids and Ruxolitinib that just
to be the answer to a call from a paper that came out on that big spook platform
two months before the second CRL (Nothing to do with the authors and obviously validating an algorithm is important but considering the strict censorship about what's allowed to be published in "top" journals, the timing is very interesting!)
(BTW Can you tell me why a top oncologist might have connections to MI5 or MI6? But I digress...)
Oh and don't forget the timing of the FDA publication stating they'd now accept a single-arm trial and the disingenuous comment that children's response may differ from adults. What another amazing coincidence!
I'm saying that the narrative that if MSB had done a
randomized study with two arms, Ryoncil would have had a better chance of being approved was a BIG FAT LIE from the get-go. They'd have ended up with a dog's breakfast like Reach2.
Also, I distinctly recall SI saying in one webcast they were willing to do a randomized trial in high-risk adults against Rux if that's what the FDA wanted and why would Dr. Prockop say what she did if she hadn't
been asked?I don't buy the potency assay issue either for reasons I've already stated. The reason I tagged you was to look at YOU who are very forcefully pushing a narrative of keystone cop level incompetence. Your asking me to accept such a ludicrous level of incompetence makes me wonder about your motives and who you're connected to.
When you said "Krause is FDA", were you implying he deliberately screwed up the BLA? Look at the timing of his departure (along with Gruber's) and note he and Gruber have the endorsement of "professional scold" Vinay Prasad who IMO has already been written into the script as being on the right side of history.
Didn't matter what MSB did, IMO back in 2020 that boot was never coming off our face. Biggest clue was Gottlieb left in 2019, as I said in this post
43544268 before Ryoncil was up for approval the following year. He would no longer be there to accuse the FDA of having blood on its hands. (You'll know whose board he ended up on and that he spends his time making sure no one questions the science that can't be questioned.)
I also noticed damage control (a narrative) in the msm and on this forum that made me strongly suspect the existence of a group which knew Ryoncil would be knocked back before the company did. That's because THEY are connected closely to whatever group make the decisions. This goes higher than the FDA IMO.
I've said before I find you disingenuous. Because of the language you use, I think you understand deep level global politics. I suspect you're a spook.
SI said at the AGM he thought the BLA would be successful. I said I wasn't so sure and he asked me why. I didn't spell out the politics I thought were going on because there wasn't time (I'll save that for my post on the AGM) but I said I thought they did the right thing but that Ryoncil was a victim of its own goodness and (I implied) the badness of something else, something both you and I know is bad.
As for what plan THEY might have for MSB, I can't say except I know what needs to happen - someone needs to save the world from the ones who are saving the world.
(20min delay)
