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So I think I finally came across the file/website that I remembered. Now that I found this again I can say it does not have the table I thought I saw that was more detailed and had in buckets but I believe this is the file I was remembering. Since the FDA IS going to average 60 days on PR letter, Amarin CAN be later as others have gotten PR in less than 60. Also it seems 69 days has been the average for Standard, not 74. SO I believe by end of day next Wednesday is highly likely we have an answer. Another note FDA has until day 60 to reject filing, no rejection letter today strong chance is accepted, I think if we get through tomorrow without rejection it's almost guaranteed no issue accepting.
There are a couple sites, the second one below is the main one I was referencing
Page 52 in here states FDA goal is to inform applicant in writing of PR by Day 60
https://www.fda.gov/media/78941/download
The below link had the tables on page 107 (look at CDER) and after. I guess I was mistaken in believing they had listed total applicants by 60 days when it is total applicants but the # is the actual AVERAGE days, you can see 144 submissions averaged exactly 60 days which is the FDA goal, vs Standard review being 69 Days (beating 74 day goal). SO it seems it is an overall goal to average 60 days, not that all those submissions were 60 days.
https://www.fda.gov/media/106231/download
I figured it's close enough I would't need it as we will know soon enough though I did just spend some time trying to find it
I'm happy if what you say comes true ASAP
I did find this one below
https://www.fda.gov/media/106231/download
Page 43 has average times and has Priority at 60 and standard at 70, the one I saw previously had a table with them in qty and the actual # of days. So it had a quantity for how many on each day or range of days. Like there was 1 Priority at 15 days, 2 and 20 days etc... with the bulk at 60 for Priority and I believe 72 days for standard but can't recall exactly that # and also it had it broken out between 100% Electronic Submission and not 100% electronic. If it was not 100% electronic then PR decision was no different in timeline than Standard review (Both 72-74 days).
Oh God, I knew you were going to ask that, unfortunately I delete my history every time I close the browser (at work)
I tried searching for the link again, I believe not from FDA website and was not a PDF file but on a website but could not find it
I did find a PDF that had old data, interestingly, from 2001 that there was 3 times more likely to get an Adcom for a Priority Review drug than a standard, 30% vs 9%
If I get a chance I'll try to do a search a bit later and see if I can re-find that info
I'm not clear on your question. I found that analyses online which I believe posted results on a while ago. It listed # of days that drugs with PR received a letter, # of days standard review got a letter etc. I believe it covered a number of years.
I can't recall all the details but the outtake was almost all the drugs that were PR got a notice at 60 days or sooner, the ones that did not were not 100% electronically filed and they got notice at 74 day letter. Standard got mostly 74 days. Now I know there seems to be evidence FDA has been a week behind on some PR approvals lately due to the shutdown backlog though not in all.
So I'm just basing my statement on the fact that historically companies are notified of PR at 60 days or sooner in the overwhelming majority of cases so if we get past Tuesday, the statistics say you are way more likely to get standard review. Thus odds go way down that Amarin gets PR if they are not notified by Tuesday.
I always expected news on Tuesday myself, I don't believe odds have changed at all yet, we get past Tuesday, odds drop considerably, we get past June 4 then we would get Standard review for sure.
I take back what I wrote here (and Just deleted), they did submit on March 15 so it did take more than 60 days assuming they press released it on the day they found out.
The transcript from the Conference call on March 15
"First as it relates to our UMD 4 pipeline product also known as AV001. I’m pleased to announce that we expect to submit our NDA to the FDA today"
A couple reasons
1)There are links on FDA websites indicating they will notify PR at 60 days when they let you know the submission was accepted (other links say 60-74)
2)Analysis of the historical data for priority review showed almost 100% of PR notices were sent at 60 days or sooner UNLESS the submissions was not 100% electronic, then it was at 74 days.
I assume Amarin was 100% electronic, if so it would be VERY unusual to not receive PR word at the day 60 timeline, but it is not 100% guaranteed that it is standard if they don't get word at day 60, just 95% or higher sure based on historical data.
Historically they have almost always given priority review notice at 60 days or less if 100% electronically filed, only in cases where the submission was not 100% electronically file have they waited until day 74 letter to give PR.
It would be highly unusual for the FDA to not give Priority review at 60 days. If we don't hear they got PR by May 28 end of day then they are getting standard review IMO. It's possible we hear on the 24th as unclear how a holiday effects the 60 days. Of course Amarin would have their 60 days end on a holiday because everything has to be extra difficult HA.
From one analyses for period 2004-2012 40% of Cardio and Renal drugs(FDA Division) received priority review (Oncology was 86.4% as the highest), 40% also had Adcoms.
Priority review is not uncommon, seems like Vascepa would meet the somewhat low standard applied to get priority review. We will know a lot more within a few weeks.
FDA averages 10.1 months on standard review so though Amarin says January approval if standard that is really the very end of January,
This just one generic company, there are many, not sure other than Teva who sells it but Teva still does so there will not be a supply shortage of generic Lovaza but clearly not enough volume for too many to be involved.
That does not mean anything in regards to BO vs GIA, they are Go it alone until someone offers a BO price they like, could come after priority review, could come after FDA approval, could be a year after FDA approval, or never but nobody knows when including management, this is not a case where they announced they are selling to highest bidder and it is selling for sure.
In the interim you need to hire for GIA because that is currently the ONLY path but once they de-risk that path may change. What if they get FDA approval and BO offers are still below company price? Now they have not maximized GIA and they are 6 months behind in some areas.
Also the things related to this job become helpful in a BO also
E.G.:
The ideal candidate will be analytical with regarding assessing circumstances and thoughtful regarding identifying or creating solutions.
Highly analytical - ability to understand business metrics, customer and market trends
Potential BP will have their consultants do an analyses on these analytics and, trust me, they will have a more negative view than you will internally, you need someone good to argue your numbers are better then theirs.
This is a good hire whether GIA or Bo.
I tried to find this info, it is too time consuming and relatively meaningless because breakthrough therapies, coupons etc. make the comparisons hard to do.
For example these are the Canada stats
Of 623 drugs approved by Health Canada between 1995 and 2016, 438 (70.3%) drugs went through the standard pathway and 185 (29.7%) an expedited pathway. Therapeutic evaluations were available for 509 drugs. Health Canada used an expedited approval pathway for 159 of the 509 drugs, whereas only 55 were judged to be therapeutically innovative. Forty-two of the 55 therapeutically innovative drugs received an expedited review and 13 received a standard review. The Kappa value for the entire period for all 509 drugs was 0.276 (95% CI 0.194 to 0.359) indicating ‘fair’ agreement between Health Canada’s use of expedited pathways and independent evaluations of therapeutic innovation.
For FDA USA
In 2018, 73 percent of CDER’s novel drug approvals (43 of 59) were designated in one or more of these expedited review categories
9 out of 59 drugs were designated in the priority review category that would compare to Vascepa
You can get a full list of 2018 approvals
https://www.nature.com/articles/d41573-019-00014-x
If I am reading this table correctly it seems standard review is by far the minority of drugs reviewed.
27% of 2018 approved drugs were standard review in USA where 70% of drugs went through standard in Canada historically.
Absolutely miniscule, If nothing can be zero then whatever the lowest possible number is above zero. Something has to come out that is not out right now (complete fraud for a wild example), based on everything out there now it is as close to zero as you can get.
If they don't get priority review IMO it will be because they don't have supply lined up to handle increased sales for a September approval until early 2020 so the point for priority review would be moot.
That's the only scenario FDA could go with to not give priority review. They will approve the expanded indication either way, I have no fear of FDA screwing Amarin on the approval part, would make no sense at all.
Assuming supply is not an issue I don't see priority review being denied.
Stock would get hit with standard review decision, that's a certainty. Adds 4 months of uncertainty, 4 months before many feel there is any real catalyst to invest, 4 months of questioning FDA motives, 4 extra months of no fun at all. At that point you would absolutely hope for an Adcom so there can be some catalyst earlier.
It was 3.4 billion in cash, rest of deal has milestones so drug sales would pay for the rest if they ever get paid. The Novartis 2q cash flow was over 6 billion last year. Also the drug already should do 500 million the next year for them, and they expect about 1.3 billion peak, so it really is not a huge cash flow investment in terms of effecting any other deal.
I go with Amarin won't exist as a standalone company in 2021 never mind 2023.
Profit will depend on timing of FDA approval, they can be profitable Q4 no problem if they don't spend a lot on another set of new sales reps and new marketing campaign but ramp up might need to happen after September approval or in anticipation of January approval.
Yahoo Finance is very unreliable with their option info, Etrade or TD Ameritrade or another broker you use is generally better, the NASDAQ site seems accurate but don't like the format myself.
https://www.nasdaq.com/symbol/amrn/option-chain
What do you mean? It's a gift of lower prices, might be the lowest price in the next 10 years if a trade deal is reached by end of this weekend and followed with priority review.
No trade deal stocks are going to drop a lot more. I hope a deal is rescued here for short term outlook.
And come on priority review....!
Restasis is 36 times Canada to USA. Prices are much cheaper in Canada, really hard to compare one drug to the next but Restasis is similarly priced in US to Vascepa but you get 5-9 billion US sales for Vascepa based on that incredibly small sample size. I just think you cannot compare drugs like that, too simple, way too many variables.
This deal in no way prevents Novartis from buying Amarin and shows they are willing to pay a good premium for 1 drug. Basically peak sales for Amarin are expected to be 2-6 times this drug depending on which analyst you want to believe. So 10-30 billion value to Amarin depending on what peak sales BP thinks base don this deal comparison.
M&A activity in this space is good for Amarin, you want companies desperate for future revenue.
I think that seems about right on to me. Though I only think 50% if TG > 135 because JT keeps saying he expects one, unclear if that's because they are asking for > 100 or just because of potential market size, otherwise I don't see the point of an Adcom for TG > 135.
The question is do they prefer to sell the company or prefer to go alone.
Just computer glitch, you can type in site:novartis.com vascepabo and get same thing but site:novartis.com vasce gets nothing
I guess I missed the Mercator post similar to mine and $700 million being the number out there for year end capacity.
Supply is definitely a factor in timing of partnership and less a factor in BO scenario.
Interesting point. I think Amarin has said $1 billion in capacity by end of year.
the quotes from last call that is most surprising to me:
" we are using the capacity of our suppliers pretty completely at this point in time."
followed up with:
We’ve not updated the – our guidance relative to our overall capacity. But we are working toward what could be a doubling or tripling of that potential overall capacity. The earliest plans therefore, being more definitively in place before the end of this year.
So is there guidance $1 billion by year end as they mentioned previously with a possible double or triple so 2-3 billion possible supply for 2020?
Or does he mean they are maxed out on supply at the $350 million run rate but expect 2-3 times that capacity by year-end?
Based on the wording and the previous 1 billion being mentiooned I'd lean towards the former but not 100% clear. If the former should be OK in that regard and no need to hold Europe or priority review. If the latter then maybe supply is a factor.
I am actually a little surprised they are maxing out capacity as their inventory level was unchanged from Dec 31 to Mar 31 so they are not hoarding inventory and growth had been good but supply should have kept up with that easily and I would have thought they would be adding to inventory.
I could also speculate that $3 billion is maximum potential supply without Amarin investing serious Capex of their own in a partnership with suppliers but maybe reading too much into the wording.
"FDA approval for a larger group of patients is a big deal. IMO. ;)"
Seems like the biggest of all deals for Amarin but then again with this stock They will get FDA approval and stock will go down because it's not quite as broad a label as the market hoped.
I feel emotionally AMRN investor need the Priority Review. Seems like it would be deflating to AMRN investor psyche to add 4 months to approval date. May need to start a support group if they get standard review. HA
I sincerely hope management is not counting on 2030 and later multi billion dollar sales and thus a reason for GIA.
They are not partnering Europe until at least FDA approval as that is when the last chance of a pre-launch BO will happen. I can't see a scenario where their first choice is not a BO. Maybe when they get priority review they can close talks after that and before final approval, maybe they need to wait until FDA approval, but then clock ticks fast.
Capacity constraints, along with a small company marketing ramp up, plus needed pipeline will all be issues that will make GIA the less likely option. Based on what they have been saying they will be lucky to have $2 billion in capacity for 2020-2021 and getting to 5-6 billion in 2024-2025 will require some AMRN large capital investment, which likely puts getting peak sales higher than that a huge question mark. Do you invest a billion into capacity gains in 2026 to get to $10 billion in sales(if that's even possible) to have generics in 2029? Good thing is generics will take some time to grow capacity so tail off might be more gradual than many expect.
Add to that they would then, like the analyst just said, need to buy a pipeline such as the mentioned MDCO and ESPR which would dilute the stock and cost some cash flow and if they need to replace 5-6 billion in revenue eventually they probably need 10-15 drugs in the pipeline so more acquisitions required.
They might be looking at $40 billion in total sales thru 2029 due to supply issues and ramp up issues of a small company. There is so much more risk in GIA. I believe 99% They will sell in BO between FDA letter and 60 days after FDA approval. I also believe it will be way less than some speculate. 35-50 per share is min and max rang IMO.
Amarin has 12 month revenue forecast at about $390 million
If you look at the Balance sheet they have to account for 10% of sales to go to the royalty bearing debt. They also have to break it out into current (next 12 months) vs. long term.
Current Debt was 34,340 on Dec 31 in line with 350 million estimate
Current Debt was 38,960 on Mar 31 in line with 390 million estimate
This would incorporate Q1 of 2020.
Seems incredibly conservative
I think market was looking to see if they could hit 80 and well short. Interestingly the first slide says 80% script increase YOY and 67% Net Revenue Increase. If revenue and script increase were both 80% you get $79 for the quarter. More where street was looking for.
I think 2Q will see a significant jump in price per script and inventory purchases that will likely make up for some of that 6 million dollar shortfall.
If they grow 15% Q over Q the rest of year and makeup the 6 million you get about 87, 103, and 118 and then 381 total for the year. Just above $350 consensus. Which would mean, barring another sales force influx in 4Q they should be positive net income in Q4.
They keep saying 5 visits to increase scripts, should see better effect as time goes on with better trained sales force etc...but when will they really hit there stride?
If they get priority review then 4Q could change revenue estimates quickly. If standard review then they need to really start seeing prescription growth to get $400 million.
That's a good point, hard to find comparisons to this situation. Investors on these boards are all close to this and talk to people about it, seems everyone is aware of Vascepa, but the reality is the vast majority of people have no idea what it is. I randomly asked 20 people at work, not one knew what it was. I know small sample size and all but mainstream knowledge of Vascepa is low.
But also is the catch 22, once they get expanded label will need high cost marketing and sales blitz. Once date of FDA approval is mostly known, if GIA, they should be hiring more sales people months before approval.
Since no company has really gone through this exact situation very hard to judge what management should be accomplishing at this point in time.
If it does stay range bound here for the next 7 months with similar up and down volatility I can knock 7 bucks off my basis selling options so something to be hopeful for if a real long haul here.
I don't know why anyone thought they would raise revenue guidance without knowing standard or priority review, if they raised guidance and then got priority review they would then need to raise guidance again right away, coupled with slower 1Q as always there was a very tiny chance of revenue guidance change before Q2 earnings.
Of course but they could say “if” standard instead of “expect” standard. Saying expect makes it look like they analyzed it and determined a likely outcome.
I don’t see that until Q4 and by then they may be back to adding to the sales force again.
If they do not get priority review and do not sell the company the stock is going to be stuck for 6 months in this general trading range or lower. Not ironic they dilute around 18 and stock hovers at 18.
I still expect priority review, I don’t think stock will move down on meh 1q numbers with priority review decision in less than 4 weeks, but if they don’t get it short term hit to stock then. I hope Amarin is just being conservative and does not truly believe standard review is most likely.
The quote was not just bolt on but:
PFE said it will continue to consider bolt-on acquisitions worth “a few billion dollars.”
Amarin is not a "few billion dollars" unless there is small upfront amount and large milestone payments.
They are doing a short term head to head study with Vascepa and hoping they can avoid an outcomes study. Results out late 2020. Seems like a shot in he dark to me in regards to avoiding an outcome study, it has shown some better data when compared to Vascepa but it’s DPA so I can’t imagine some better numbers on certain things would lead FDA to agree to no outcome study. Seems unlikely to challenge Vascepa but something to watch if they, by some miracle, somehow avoid an outcomes study.
There is a guy on Seeking Alpha been posting a real portfolio invested for 10% yield long terms using BDC and MREIT, has a number of stocks listed might be helpful for future purchases.
https://seekingalpha.com/article/4252152-2019-first-quarter-update-10-percent-high-yield-stocks-massive-recovery
His strategy offsets the fact BDC's may do worse in a recession by putting half in MREIT's
"BDCs' performance is tied to the underlying borrower's ability to borrow or repay. In times of economic stress, borrowers' willingness and ability to lend and/or repay declines, negatively affecting BDC performance."
""Agency MREITs (by design) are negatively correlated to the health of the U.S economy. Stated another way, when the U.S. economy is performing poorly, Agency MREITs tend to outperform."
That number needs to be taken in context:
debt to GDP will hit 78 percent this fiscal year—twice its average over the past 50 years. Debt to GDP could eventually reach 90 percent or higher, the same as it was at the end of World War II.
Growing GDP by growing debt is fools gold. But short term thinking has done this country so well, I mean, no bubble economies at all that then come crashing down, except in the 1980's, 1990's, 2000's, 2010's, well if you eliminate those decades then short term bubble creation has worked well.
Good thing is when they do the Ronald Reagan reversal and have to put in a massive tax increase to make up for the "Oh Crap it does not pay for itself" tax cut Amarin or it's BP owner will be a nice place to park your investment when the rest of the market crashes.
I miss the Fiscally responsible republican party. Now we have two parties that Spend, Spend and Spend but only one tries to raise the money that it spends, the other just borrows it. Lose, Lose, Lose for the rest of us in the long run.
Was doing some Due Diligence on Patents and remembered this post after I saw this article from 2012 written by friend Adam Feuerstein was relevant
https://www.thestreet.com/story/11598407/1/amarins-patent-problems-fading-fast.html
Seems like this one patent is considered very big and relieves a lot of the tension related to whether patents will hold up. Thought might help with the original question you had.
Key words from it:
Importantly, these patents should provide Amarin with market exclusivity for AMR101 through 2030.
Short interest had not much change though with volume down over the period the days to cover went from about 2 days to about 4 days.
4/15/19: 21,911,936
3/29/19: 21,149,076
3/15/19: 16,859,967
2/28/19: 17,514,524