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ramfan60

01/17/23 10:54 PM

#398601 RE: Whalatane #398592

Because R-IT confirmed Jellis so why do we have to confirm R-IT. To satisfy whom? You? Will it change anything related to our fortunes in the US? No. Will it change anything related to our fortunes in the EU or ROW? No. Will mining Kaiser patient data satisfy Nitwit Nissen and the other doubters that have their own agenda? No. So let's just call this data mining exercise MITIGATE and see if it has any beneficial anti-Covid effect on those with CVD risk. If not, no biggie because nothing else is proven to have the beneficial effect we seek so no downside to the study.... just disappointment. Now if there is a statistical benefit.... then as I said, only upside. I hope it shows a benefit because we become much more valuable.
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Laurent Maldague

01/18/23 3:33 PM

#398677 RE: Whalatane #398592

Kiwi, I honestly can't make heads or tails on the MITIGATE trial and what to expect.

Things that give me pause:
Poster on twitter said she was enrolled, and the trial only lasted one year
On clinical trials.gov the timeframes for each endpoint is 0-12months
Dr. Ambrosy said followup was 6 months min and up to 12 months.

Things that give me hope:
The trial supposedly doesn't end until Feb 28, 2023, implying > 1 year follow up
KM vaguely alludes to "real world evidence" at JPM conf
Clinical trials.gov also states:
"Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion"
Lastly, even if we ignore CVD, the trial investigators were noticing low Covid related event rates, so may have been forced to extend followup regardless of intention to capture CVD.

I really do hope Amarin/investigators had the foresight to leverage MITIGATE for CVD. The last thing I want to see is another tweet from Bhatt saying "I asked for a longer trial, but Amarin refused due to budget constraints", similar to the tweet he made after PrepareIT 2.