Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
MITIGATE, JAMA, JACC
Why will MITIGATE's preliminary result be published in April? I could not find negative result in publications of preliminary result.
MITIGATE will be presented at ACC and published in JAMA and JACC
Kiwi,
Kiwi,
Kiwi,
Re: MITIGATE trial
From my understanding, Kaiser announced that they had recruited all participants at the end of August, 2021. However, according to clinicaltrial.gov, several changes were made.
September 3, 2021: Overall Status- Recruiting, Enrollment- 16500
December 13, 2021: Overall Status- Recruiting, Enrollment- 39600
January 7, 2022: Overall Status- Active, not recruiting, Enrollment- 39600
I guess they decided to increase the number of enrollment at some point between September and December, 2021, and completed recruitment between December, 2021 and January, 2022.
Now we have Vascepa-arm 3,600 and usual care-arm 36,000.
The percent infected would be around 50% for 12 months (1,800/3,600 treated with V vs. 18,000/36,000 with usual care). Hospitalization rate would be 10% among those infected. (healthcare utilization rate may be 30% which means 15% of total population).
If healthcare utilization rate is 13.7% in V (493/3,107) and 15% (5,400/30,600) in usual care, p<0.05, which means we need about 10% of relative risk reduction because of V.
They also have changed their primary outcome to:
Time frame for URI has been extended to 12 months from 6 months. We may see the result at the end of this year or early next year.
I except that they will present the result (COVID) at ACC in April.
Kiwi, MITIGATE must be interesting
Kiwi,
If growth of prescription rate remains stagnant, yes.
I don't know if AMRN really needs AG.
Kiwi, from MITIGATE protocol
PD, I don't know the correct answer, but you may see this website interesting.
https://data.thecalifornian.com/covid-19-hospital-capacity/california/06/sacramento-county/06067/
This is the matter of psychology, biases, and perceptions. Vaccines are well accepted due to the current circumstances, but Vascepa is not, unfortunately.
BBI,
I agree that MITIGATE should be interesting based on my experience.
Promotion as "THE STATIN ENHANCER" is just to change the perception of community. The issue here is there is no evidence that Vascepa is enhancing statin directly. Vascepa most likely has benefits on its own.
ralphey, I agree that Vascepa should be promoted as "THE STATIN ENHANCER.", not as lowering triglyceride. At least for short term (for the next 5 years), that would be the best way to change community perception. IMO
PD, I disagree.
Ok, thanks!
Do you have any info regarding HAS conference held yesterday?
Thank you for the info!
Pricing & Reimbursement of drugs and HTA policies in France
https://www.has-sante.fr/upload/docs/application/pdf/2014-03/pricing_reimbursement_of_drugs_and_hta_policies_in_france.pdf
Thank you for the info! This is what I was waiting for.
Agree. I am buying constantly at this price.
Yes, it's expensive without insurance
No prime discount for generic
IMO the 537 patent is strong and will be valid until 2027. I can't see how Hikma can show the obviousness of Jelis based patent, but never knows...
CVD risk reduction
correction: according to Merck's PR, p=0.0218
I would take V instead
If the data is true, p-value is .052499. Statistically not significant.
Most likely Amarin does not need additional CVOT for once a day formulation. Only need bioavailability (BA) and bioequivalence (BE) test.
https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-—-General-Considerations.pdf