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40 percent of total Vascepa sales was mentioned or just Tg>500 pop?
Yeah it’s so unclear how they are separating the two trials. Amrns guidance for mid 2021 doesn’t make sense if we can get results end of March
Slide deck is fully updated. Nice to see. I also like seeing
USA - multi billion opportunity
Europe - multi billion opportunity with no competition.
Rest of world /China etc - multi billion opportunity
We really needed BP in our corner. However there’s still hope to turn some things around. Dreams of 100/share aren’t looking good but we have tremendous upside from 5 bucks.
Answers below
Anyone care to explain how Matinas is up 30% today because the FDA gave
a tentative approval for the name of its drug?
-it was up bc of big insider buys. Price and volume has been up
Of late. Enhance it trial readout vs Vascepa is imminent as well.
How do they get away with
calling it a Cardiovascular drug?
-It can be in the future. Agree it isn’t one yet. Even approval for their TG label will take some time.
Why does the FDA allow Omega-3's
with DHA when pure EPA is what has proven to be effective?
-Epa blood level was what mattered the most in reduce it. It correlated the closest to the primary outcome. TG reduction accounted for the very small piece that was left (as per bhatt). That doesn’t mean that a product with other compounds in it can’t achieve the same or higher epa blood level and still contain some DHA. Lastly, MTNB is first going for a TG>500 indication so pure epa doesn’t even matter for that indication bc pure epa probably leads to less of a TG reduction then other compounds on the market.
Why won't
the FDA simply end this BS? Isn't the job of the FDA to not allow
dangerous and ineffective drugs? Why is this one situation so hard?
-It hasn’t been proven dangerous and ineffective. I get the frustration but there is no conclusive science showing MAT9001 is dangerous and ineffective.
-I’m long amrn but have disclosed many times a position in MTNB as well which now (and sadly) has given me a larger gain than amrn has. I don’t think enhance it data should affect amrn stock price bc it won’t hit the US market for years and amrns US market is in question as we speak anyway.
Ya the tweets r infuriating. It’s almost like they don’t even try.
Well I think what matters most is if it works. And both Eli Lilly and regenerons studies failed if u actually read the data. I’ve been through it countless times already and it seems ID has as well as they don’t think it works. Additionally theres no patient oriented outcome whereas with Vascepa trials there are. Therefore it (as the article is stating) is not Given often to patients. On the flip side, Vascepa has more positive data for covid then both of the above therapies. I think if one more readout is positive we will be golden.
I didn’t even see GBS with this. But anyway yes super safe. It’s a risk benefit scenario and you couldn’t have a more favorable risk benefit scenario than this one.
So u think the mRNA vaccine potential long term side effects (aka a vaccine that dissipates quickly in the body and resides outside the nucleus where ur genetic code is) is higher than the risk of covid related morbidity mortality or long term effects which are shown over and over again.
Very surprised you think that way and would defer a vaccine at this time. I get the child waiting bc no data on them but for adults that way of thinking is very hard to accept.
I am so confused by your message. In no instance does a 20 percent risk of side effects outweigh getting the vaccine. I hate discussing covid on this board but the side effects are insignificant compared to the protection of a vaccine. The side effects can be even higher and it would still be beneficial bc the side effects are temporary ~24h and non deleterious
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
Let’s get back to focusing on amrn. Too much covid on this board and we see enough of that everyday.
Yeah similar except for fact that they aren’t. You clearly have not read the briefing documents.
For one Age >65 efficacy is 86 percent for moderna.
That’s wrong. As of 12/12 only around 1400 randomized and it’ll be 60 days on therapy. so can’t complete in Jan
none that I’m aware of and just about all of them had inferior news.
Bhatt basically just said nissen is an idiot without saying it. drug benefit and not placebo harm is clear given epa level accounts for 98 percent of the benefit in reduce it. that can’t happen with a placebo issue.
Problem is it’s taking too long. Prepare it is closest but hard to see news before March if we aren’t even fully enrolled 12/12 and then it takes 60 days.
That’s the big question. Can they get an EUA. Be the most bullish thing that’s happened to this stock in awhile.
1430 pts randomized as of 12/12 according to Bhatts slide on Twitter. Pts on Vascepa 60 days. No way prepare it can complete in January then.
Zinc vitamin c steroids remdesivir are the most typical standards being used to my knowledge.
Do you think you are acting rationally? I get the emotional rollercoaster we have been on but this does not seem to be helpful. I’ve probably been in this as long as most but this is just not going to help.
Let’s see what happeneds we have a lot of other reasons to be bullish in coming weeks.
True story ha
Same. I’m kinda wondering how explosive the news will be. If it weren’t for covid I would say it’s a watch and wait but every covid stock has gone nuts on news and this is already approved is safe and is on the market.
Yes. However we won’t know that answer in the phase 2. That’s a phase 3 answer from Argentina. The phase 2 will show us important info about reduction of key lab markers associated with severe disease and mortality.
With the way the crisis is Phase 2 may be enough for EUA to be honest. Someone else with more regulatory experience can weigh in but I’ll know what docs think in the first week of the news. Covid data has been watched closely and acted upon quickly. If vibes are good they’ll be prescribing it off label. If not then it’s Good news but we wait.
I mean look at Eli Lilly antibody cocktail. That’s authorized on a phase 2 and I give that out daily but it obviously has much stricter criteria to qualify for than would Vascepa.
It won’t be skipped but if physicians like the result they can start prescribing right away off label bc it’s already on the market obviously.
Many limitations.
52 participants in the mask group and 39 control participants reported COVID-19 in their household. This creates a bias favoring not wearing masks
It is unclear how well other public health measures were being followed in this trial
Self-administered tests and self-reported compliance means likely much lower numbers than what is reported
Trial did not test the role of masks as source control of SARS-CoV-2 infection (i.e. masks preventing acquiring infection not spreading infection)
Study not powered to see protective effect of masks for other viral infections
Conjunctival routes of potential infection were not accounted for (i.e. eye protection)
In patients who wore masks it is unclear if the masks were worn correctly
Loss to follow-up was 19%
Relied on patient-reported findings on home antibody tests
Changed the primary outcome during the study from reduction in COVID-19 infection frequency
That guy is a joke. We have disputed him every time. He got lucky we lost the case but was wrong with everything else.
This seems overall bullish. I just wish I understood this law suit more. I want more info etc. it’ll take time to absorb the ramifications of this.
Unclear what Mochida gets out of this but that 537 patent to me looks the most interesting to go to court with.
I’m just wondering uptake by physicians based off the results (even before approval ). Ive talked to a few colleagues and so far it seems most don’t see why not. I can start prescribing it off label 12/12 but will others. It would need to make national headlines to garnish some legitimate uptake. 100 pt trial isnt big but it’s something. Also it’s not a patient oriented outcome study. However there’s enough evidence to date showing CRP correlated well with disease severity. Makes sense to try it on people if Vascepa can reduce CRP (primary outcome) and other inflammatory markers (secondary outcomes). I’d want to see disease severity score lower too (secondary outcome measure )
Zip u think physicians will start prescribing based on a positive trial here. I’m
Trying to get a feel
For the medical
Community from a PMD/outpatient standpoint. This would be more an outpatient prescription. I worry about insurance coverage on it.
Qs is if the trial is positive can it get us any sales here and or abroad. You have to think yes but just how much is the qs.
I tend to think the trial will be positive. CrP is highly correlated with covid disease progression and severity. If amrn can reduce CRP it is a surrogate marker for disease severity and many people may be prescribed it early on.
Is that the only supplier though
How quick is approval for China? Anyone know
Congrats longs. I think we are going to turn this ship around soon.
Agree.
Friend got denied twice from United healthcare for reduce it indication. Now tried the 9 buck coupon (as low as 9 bucks )for 90 day supply and got charged 546 bucks as a cash customer with that coupon. It would have been 1 k without the coupon. Crazy how we aren’t further along at this point.
I was wondering the same thing. Hope someone knows.
He’s entitled to his opinion unfortunately. He has alternative motives for sure and Bhatt knows it too.
Only benefit is you can add skepticism to our future obviousness court case on reduce it as he’s still skeptical lol. Man he must be paid well by AZN.
That is unreal. I can’t believe it.
Isn’t next Europe update this week or no?