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Sorry it’s just too soon to give you fair feedback.
The drugs are being used widely. Nearly everyone in the unit is on hcq/z pack. The harder issue is sending people home as outpatients on it and that really isn’t being done nor should it probably be done. We are reserving it for inpatients (sick sick pts) mostly as the studies continue to come out and even more case based info comes out each week. Hoping we have something here as normally I am evidenced based but without much else to offer I think a sick admitted patient should be offered it. I am not seeing a shortage on the inpatient side but I know outpatient people have stocked up on it and some pharmacies are temporarily out.
MRCs most recent Post demonstrates his lack of DD and conscious attempts to confuse amrn Longs. He uses Mori 2000 as conclusive evidence of Obviousness.
Few facts
-Trial has 3 arms of <20 pts each (total joke by scientific measures in terms of size)
-Trial enrolled pts with Tg levels of 2.01 +/- 0.19 mmol/L which is 177.88 mg/dL +/- 16.81 in our metrics. This is no where near TG> 500 which is the question at hand. Total irrelevant study to draw conclusions off of.
-Conclusions of the article if you actually read it lean towards DHA as the superior omega clearly demonstrating EPAs effects were not at all obvious.
-MRC should practice ‘social distancing’ and remove himself from social media. PERIOD.
ICU Hm I haven’t been up there in awhile. I believe ~36 Adult. But we can take on probably more than that in a crisis by flexing up our step down beds and ER beds can act as an ICU hold etc
Update from the ground level - I haven’t read many posts lately bc not much happening with amrn until Judge Du decision. Our bigger issue is the market conditions.
I can say we are now informed the virus is NOT airborne. DROPLET and Contact only. So hand washing and staying 6 feet away from those infected and your risk of transmission is very low. That is important bc airborne and the spread would be much worse which was our big fear.
Additionally testing is picking up , tents outside hospitals are going up to keep those infected away. The response has been aggressive.
Lastly, I have not seen real sick people being admitted at all over the last week or so where I would expect numbers to really get crazy. In fact none with septic shock or BL pneumonia and I’ve been there 6 straight days and go in tonight and tmw as well. Flu cases have gone down as well bc of everyone’s good hand washing last few weeks. We have tested covid people and they get sent home.
Overall I think our fatalities in Us is going to come in low and I think our response is aggressive at this point and may be just in time. Hoping next few weeks we see case numbers go up (bc of testing) and overall fatality percent go way down.
I agree with you on ACC. I was incorrect in predicting the conf would stand. It hasn’t been canceled in 70 years. Long time. However because a conf is canceled does not mean this is going to have ICU stays or lots of deaths. It’s merely to not quarantine health care providers bc then we can’t work. The numbers so far are a joke compared to the flu or other types of serious illness. It’s great to be prepared for the worst and be happy if it’s not as bad. Will c !
Northeast. I’d prefer to keep my exact location not public. thanks.
I can maybe add some as I am on the front lines of all this. There’s a lot confidential right now as I learn more each day. Case numbers will be going up. However it is not true that most tested are sick (icu level sick). You can test and send home if there’s a link to an infected country or person of interest. I have not seen very sick people coming in recently requiring icu care. I don’t think this is going to be an ICU issue. The vast majority will get better at home. I see the bigger issue as the economy and jobs being shut down and travel suspended etc. we will get through all of this.
All excellent points. I think the distinction has long been made from a medical standpoint and also cannot see Judge Du failing to see that.
Thanks JL. No worries.
I was merely providing a counter argument as suggested. I don’t think this is the avenue to call me not a bull. I’m
Sure I have as much on this as you do. We are on the same team here.
-Joe
Interesting. I’ve actually looked at both sides and went back and forth with my lawyer friend on it.
The main way for the defendants to win obviousness is if the judge does not set a distinction of TG> 500 and less than 500. I think that distinction will be key. If they can appreciate the distinction than all of the evidence cited does not adequately study the population of TG> 500 and thereby there’s no prior art.
The way the defendants can argue no inducement is by winning the argument that high TG is not a chronic condition. They’ve made the point that there are instances where it can be acute but it seems to be the conclusion of both sides that it is “generally chronic.” If its not chronic, then with no link to a duration of treatment on the label it will not be assumed for Vascepa to be used indefinitely and thereby they don’t induce.
For the record I’m bullish for Amrn (very) but just providing my thoughts for you.
Agree with you. I feel as though the lawyer yest just got paid to read the post trial briefs and state his thoughts. Many on the board (including myself) have read everything we can get our hands on including hundreds of pages of finding of facts, the case laws from
Sanofi Bayer etc etc. I pulled all the scientific articles referenced as well which are actually not easy to get bc they were so old my hospital librarian had to go outside our inner circle to get them. Anyways, point being the obviousness argument is a slam dunk. The fact that he didn’t see that is not to say he is not intelligent it is just that he has a small portion of the whole case in front of him. Additionally, we all have not been able to see the trial where I can imagine expert testimony further reinforced our argument in front of the judge.
I’m heavily invested in amrn and each week that goes by I can admit I’m
Deeper in the red. I am continuing to add through options (selling puts every week) and have no downside protection. However there’s no price I would be forced to sell at because I know we are coming out ahead.
Hold on all!
The thought process is conversion
To epa and potential for better bioavailability than Vascepa. I’m not alone. Many brilliant minds are now a part of the mtnb story with another one just being added this week. Again, we can all discuss end of year when the H2H study is done and we can look at the epa blood levels. However if I’m right the stock will be at a multiple to where it is now. I’m
Fairly confident the odds are in mat9001 favor. Will c.
That wasn’t the point.
I agree for sure if this trial shows higher epa blood levels it won’t get them a CVD label on that trial alone. My point to JL was what his opinion would be on MTNB if they show higher epa blood levels bc currently he is stating it is a useless company (and I respectfully disagree). I think that changes everything.
Your point is a good one and I agree as it relates to amrn. The point is not that amrn is a bad company with heavy competition on the way. The point is mtnb is a great spec play at an early stage with upside potential multiples and multiples from where it is now. It can be like buying amrn around the time of the marine trial (which I did many years ago).
I hear you. They can’t get the reduce it label without a CV trial. I think they may try based on epa blood levels in a few years when time comes but I agree fda will be strict given all the failures In the space.
My opinion is they can get the Tg> 500 label fairly easily by 2023 and if their epa blood levels are higher than Vascepa they MAY get some physicians to prescribe it off label for the reduce it population over Vascepa. I agree down road they would need a CVOT for any legitimate billions in sales. However with a market cap so low even if they can get to 400 million in sales that’ll be enough to move that stock a high multiple from where it is right now. Just my thought.
I agree with you near term there’s no major threat. Mtnb still has a lot to prove and do if and when they hit the market. I’m hoping the amrn story is over by then. I’m looking for a BO in next couple months max.
And IF mtnb can show a higher epa blood level than Vascepa, what would be your thought at that point ?
Agree. This thing is primed for a major breakout. “The bigger the base, the higher into space”. We have done nothing for a year just a large range up and down.
I don’t think 30 is very far away. We always talk about the next over hang with this stock but with Epanova knocked out and us getting a patent win (assumed end of March) you have to believe offers come in fast. I think we got dealt a huge win with AZn strength trial failing ahead of time.
Thanks for posting. Looking forward to the conf.
Interesting trick. Thanks for sharing.
No not at all.
No one ever said that. After approval for Tg>500 they’ll need a CV outcome trial (if they want reduce it population on label).
I can’t comment more than they are saying in their conf calls regarding that.
Updated conf call is Monday.
“Matinas intends to initiate a number of studies, including a 28-day comparative bridging toxicology study and a comparative clinical bioavailability, further assessing PK parameters of MAT9001. These studies are designed to support a potential U.S. Food and Drug Administration (FDA) approval. The Company also plans to initiate an additional head-to-head study vs. Vascepa at beginning of 2020 and data expected in the 3q 2020”
They said they were submitting 2022 expected approval 2023 last I checked. Lots of time for trials. Funded well into 2021
“As a matter of fact this is a big enough concern that it might preclude it from ever being prescribed as a chronic medication for lowering just TG! Further, even if it lowers TG, why would anyone prescribe it when you could prescribe Vascepa and know that you are lowering TG and CVD risk? That would just be dumb. And if it is price you are concerned with, well there already is generic Lovaza for TG lowering.
Conclusion: MAT9001 is dead in the water without a CVOT.”
I’m bullish on MTNB as a spec play. Everyone is entitled to their opinion. Next conf call is Monday. I don’t think the data on Dpa and stroke is strong enough to count out MTNB at all.
-We don’t know the risk of stroke in MTNBs drug and it is possible the epa is protective despite the dpa component
-MTNB EPA blood levels compared to Vascepa is why a physician MAY prescribe it over Vascepa (enhance it trial must show greater epa blood levels or its dead)
-MTNB MAY have other beneficial effects including reduction of other lipid markers and pcsk9 that MAY be superior to Vascepa (enhance it trial must show this)
-Lastly, agree down road MTNB will need CV trial but for now if they can get the TG> 500 population and get sales of 400 million like amrn that’s pretty good considering their market cap is so small. Stock would soar. Additionally, plenty of doctors WILL prescribe mtnb >Vascepa for reduce it population off label if the epa blood levels are higher than Vascepa even without a CVOT trial. We await the epa blood level results from amrn in a few weeks at ACC 2020.
I’ve debated all this a number of times with people. If you want to wait until enhance it is done I can be wrong if it fails. However If its positive I think MTNB can come to market 2023 and will sky rocket on trial results end of this year. Baker brothers took a small position so it’s not totally idiotic. This is not including MTNBs LNC platform which has multiple partners including pfiZer testing their product. Good idea to own both stocks -MTNB and amrn. I have 1/4th mtnb position than I do amrn. MTNB has higher upside potential bc it’s so early and way more speculative. Amrn is better overall and less risky bc it’s proven already. In fact you would be crazy not to buy amrn at these levels. My last buy on amrn was exercising my options last week bc I’ve been selling puts every week. Massive upside ahead with generic win.
GL.
Won’t be a virtual conference. It won’t be canceled (IMO). Doctors are the least likely to cancel. I may be there. Trying to get off for the epa presentation but having hard time getting coverage unfortunately.
GL
Agree and thanks for your posts. It seems that the Federal circuit in Bayer established “the entirety of the label” argument. Sanofi had a reference to the clinical trial section in their indication and usage section and we do not. Sanofi has no duration of treatment listed for their chronic condition of afib. We have no duration of treatment listed for our chronic condition of severelY elevated TGs. However we don’t tell the reader to go look at the clinical studies section like Sanofi does with their drug Multaq.
I think as long as Judge Du correctly applies federal circuit opinion that the entire label applies (therefore you don’t need to direct a reader to section 14 of the label), a reader looks at the clinical studies section, sees the marine trial of 12 weeks and generics thereby lose. Period. I don’t see how we lose aside from some freak event but we will all find out soon !
It’s as strong bc the Bayer case was higher case law. Federal circuit case law saying the label should be taken in its entirety. Sanofi establishes “some physicians” as all that is needed to induce infringement and also parallels our case as theirs was 12 Month duration of treatment and ours is 12 weeks. Cases r so closely tied it’s an easy application of law for the Judge. Sanofi indications and usage directed the physician elsewhere on label which is why ours is slightly diff. However this was prior to the case law clearly demonstrating entirety of label to be used as stated in the Bayer case. Also 2018 fda guidance document stating “Other sections of labeling (e.g., DOSAGE AND ADMINISTRATION,
57 CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, USE IN SPECIFIC
58 POPULATIONS), as applicable, also provide essential details that enable safe and effective use of a drug, and labeling should be considered in its ENTIRETY for individual prescribing decisions.”
Thanks great post. I agree with you although my opinion is of less value than yours. Thanks.
Have you read the briefs? Your post is so Misinformed it’s beyond an explanation. It has nothing to do with the percent at all.
Clearly he is over reacting. Nothing new in the briefs. That info is not new and is already disputed. Majority of cases of severe TG according to our label after diet and exercise are chronic cases requiring indefinite treatment. I read both briefs. Obvious win for amrn without a doubt.
Makes no sense to sell here. This is where you buy. There has been no bad news. It’s just a waiting game. As long as you can wait this is going to go up dramatically. Nevertheless profit is profit. GL.
He did mention How Vascepa can have benefit in NAsH and the active trial going on with Gilead. First time he’s ever mentioned this. But then it got cut off.
Conf call - Really not answering the DTC qs. Why is this not starting until mid 2020 if they already submitted and it takes 45 days. Other than that seems like Europe negotiations will move fast once 120 day letter reached end of March. I see something happening fast once trial over. BO would be what we want.
They never released when the 9 month period ended. If you add another 9 m to the release of the results at AHA in Nov you arrive somewhere in August. Even if the trial finished a few months earlier than Nov 2019 release, it’s still going to take time to compile the results and they would definitely be presenting this at a major cardio conference so I don’t see it coming out in the next few months but maybe late q2 early q3.
Only reason these conferences are good is bc of the Q and A. Hopefully someone asks why his DTC campaign hasn’t started and when these new sales reps are hitting the ground running.
I think most would agree with you. I’m still In the camp that I believe he can be a genius after all. If he holds out and gets the right offer. If nothing materializes within weeks of the generic lawsuit win I’ll change sides and think he’s a POS. Until then I think this is all a means to an end that is probably going to be here before we know it.
Agree. No hedge here. I have June calls as well for additional exposure just bc of the unknown exact timing of the judges decision.
Additionally each week I’m selling puts bc the price is so stagnant.
Can’t wait for the decision so we can get back on the BO train.
Thanks. Everytime I look at the brief I just love this one paragraph. It’s almost a win right there.
In remarkably similar circumstances, a recent district court opinion found infringement with respect to a claim directed to treatment “for at least 12 months.” Sanofi, 204 F. Supp. 3d at 683–84. There, as here, the Indications and Usage section of the labels did not limit the duration of the treatment. Id. at 683. There, as here, expert testimony established that the indicated use was for
a “chronic disorder” for which clinicians intended administration of the drug “indefinitely.” Id. There, as here, the label reported a clinical trial and the length of that trial would further encourage clinicians to administer for at least the claimed duration of 12 months. Id. at 683–84. The same result should be reached here with respect to the “12 weeks” limitations.
I’m not sure I completely follow your here. They want to instruct physicians to prescribe generic Vascepa for less than 12 weeks to circumvent the law. They know most physicians will be prescribing it for life and they’ll make tons of money. This is legal if it just happends in that circumstance. However , The case is whether they are sort of promoting that behavior or encouraging at least some physicians to prescribe this way. It’s fairly evident they are encouraging that behavior when you look at the Sanofi Case and ours and the similarities present. Our marine trial was 12 weeks. If a physician follows the labeling which is looking at the trial the label is based off of , in order to get the lipid parameters seen in Marine you need to prescribe Vascepa for at least 12 weeks.
Lmk if this wasn’t your qs.