Is it worth trying bigger study for Vascepa? NIH or Oxford? Amarin won't unlikely fund it.

Some will ask, why the study was so big.

The answer:
- Aspirin is cheap & widely available
- COVID-19 is common & mortality remains high
- Even a small reduction in the risk of death would have been incredibly important
- To detect small effects requires big randomised trials

— Martin Landray (@MartinLandray) November 18, 2021

We could have and wanted to do a larger trial, we knew the trial was going to be underpowered when we saw the blinded overall event rate, but no additional funding was available to continue enrollment. We believe the 15% is likely real - hopefully NIH or Oxford will test it.

— Dr. Deepak L. Bhatt (@DLBHATTMD) November 15, 2021

I see. Thank you!

His comment on this twitter (

Thx Mark! Couldn’t agree more

— Pablo Corral MD (@drpablocorral) November 11, 2021

Most likely he meant "revise=re-read or review", not "revise=amend or rework".

The fact is he was referring to late breaking trials, and he knows that at least one late breaking trial "used" win-ratio, and it will be most likely presented at AHA.

And it is most likely Prepare-it 2.

Raf's questions was "Are you talking specifically about PREPARE-IT-2?"

He could say "yes", "no", or just ignore.

If he says yes, he will break AHA embargo rule. I don't know why he did not ignore Raf's question. Probably he was too nervous to ignore the question because he was almost against the rule.

He can't say anything, but "no".

If Dr. Botto was referring to PIT2, the result is likely the following:

Primary outcome
Composite outcome (hospitalization or death): statistically NOT significant

Secondary outcome
Hospitalization: statistically NOT significant
Death: statistically significant



If he was not a supporter of PIT2, the result could be:

Primary outcome
Composite outcome (hospitalization or death): statistically significant

Secondary outcome
Hospitalization: statistically significant
Death: statistically NOT significant

It seems that the collaboration with PFE on ROW is not thought to be positive based on SP action.

This is old news

That's not the correction, but my hope.

I am not sure in what kind context Dr. Corral was upset, but PR of COVID trials without peer review is nothing unless the medication in trial has been already marketed or you were short term investor.

But medical professionals may have bias that pfizer is probably right.

I don't think so, but it will be reviewed by FDA through EUA process.

Kiwi, omega-3 effect on triglyceride level is difference based on baseline triglyceride level. 2 mg/dl drop looks too small, but could happen if baseline TG level is low. Do you know their baseline TG level? I agree that poor medication compliance in PREPARE-IT 1 could be the reason of too small drop in TG level, but the deference between V and Placebo (-2 vs. 7 mg/dl) is still significant (not statistically though)

Considering my bias and hard outcome/inclusion criteria of P-IT 2, 50-50

We can't conclude that young benefited more than the old given trial design of REDUCE-IT. However, in general, the old have more irreversible conditions at baseline (eg, more atherosclerosis in arteries at baseline which did not improve with V) and/or can get more complications/new diseases than young.

Raf and Kiwi, it seems that people < 65 yo who met reduce-it criteria may have more benefit from Vascepa than those > 65 yo who met reduce-it criteria. Baseline CRP may not have any association.






I don't really care V's TG lower effect in healthy people (PREPARE-IT 1).

Rose, I agree with you. As far as I know, only 2 studies may support the effect of EPA on CVD: MITIGATE and RESPECT-EPA. I don't think we will see additional studies in the future unless Amarin is willing to do it (eg, high dose EPA (8g) in patients with ACS, acute stroke, etc).

Would you use Fluvoxamine in patients with COVID-19? Maybe, but maybe not. Vascepa needs stronger result.

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext

Hikma's catalog still says "hypertriglyceridemia".

https://www.hikma.com/media/3056/2021-hikma-non-injectable-product-catalog.pdf

Rose,

Rose, At least 1 person was >500 mg/dl which is important in US legal system.

Did you see the link I attached?

They included >500.



https://www.jacc.org/doi/10.1016/j.jacc.2019.06.043?utm_campaign=twitter_post&utm_medium=social&utm_source=twitter_post

PD, markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) MAY increase the risk of developing pancreatitis.

VHTG MAY increase the risk of developing CVD.

Is there any difference?

Weren’t we talking about “launch”?

Title: "Can the third PCSK9 drug succeed where the first two failed?"

Payers spoiled the debut of the first two PCSK9 drugs from Sanofi and Amgen. A third is poised for approval — but if history is any guide, its U.S. market-access path will be anything but smooth.

https://www.mmm-online.com/home/channel/features/can-the-third-pcsk9-drug-succeed-where-the-first-two-failed/

Agreed. That is why settlement is not a good option despite the risk of losing a lawsuit.

Kiwi,

How about this, "not exceed certain amount of weekly script (10,000-20,000) until RIT patent expires"

To keep and not exceed 10% of market share regardless of indication may be an option.

alm,

Kiwi,

Kiwi,

This is an example of appropriate label which generics should have done for GV.

Everything is colchicine, but only COLCRYS is indicated for acute flare.

Kiwi, I don't know Dr.Reddy's label, but Apotex and Teva can sell GV with appropriate label in the future.

Amarin needs to win, not settlement from my viewpoint (not lawyer), and Hikma will pay everything.

Amarin to settle with Hikma, then other generics will replace Hikma's market share?

Haha, lier