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PlanTrader

07/01/21 5:21 PM

#39724 RE: The_Q #39722

@The_Q, But how they could have done that, when the need for chemo isn't determined until after surgery (correct? or no?)... yet MK is administered prior to surgery? Nobody has addressed that, not even the company aside from saying something about having a way to figure that out in advance. Really? How?

So that's the catch, isn't it? MK would have to be applied to every patient in order to end up adding a clinical benefit to 40% of them. Maybe that's fine, maybe it's not and it means more trials required in order to identify a way to determine lack of need for chemo upfront. If the company really knows how to do that, I assume they would have explained it at least a little bit because that's a hugely important caveat. It would mean NOT having to head down the path of approval to give MK to every patient. Wouldn't that idea be received more readily? Yet right now, nobody has commented on a way to determine it.

One might say, well SOME patients are obvious non-chemo patients and it's known upfront. True. But in that case, the population would be much much smaller than 40%.
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frugalNorwegian

07/02/21 5:20 PM

#39809 RE: The_Q #39722

Q - Here is a P3 study that passed its primary endpoint with only 62 participants.

https://clinicaltrials.gov/ct2/show/NCT03566238?term=pfic&draw=2&rank=4

Here are the results of that P3 study.

https://seekingalpha.com/news/3612011-albireos-odevixibat-successful-in-late-stage-study-shares-up-74-percent