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.
Everyone can just stop trying to figure out the Adcom rules/regulations.
The FACT is simple.
The FDA is being unreasonable and there is no accountability to them on it and their silence causes doubt.
They are all powerful in this regard.
They could end all of this by simply informing AMRN they have no plan for an Adcom at this time which still leaves the possibility open later as I said they can do basically anything. Move PDUFA date etc...
Compounding the silence is the reality they often tell sponsors when no adcom is planned.
Add in the large secondary and there is plenty to fear and why we can't seem to get moving. I hate it as much as anyone.
I'm sure JT is pissed about the silence, but there is nothing AMRN can do except prepare for all eventualities keep silent and keep working and that's what they seem to be doing.
I for one am really ticked FDA has done this. No excuse for it this close to the PDUFA date, 64 days whether holding the adcom or not.
Elf and JL,
I agree with you both and will add that I believe the approval is coming sooner than most expect.
I expect shock waves very soon.
I agree. I think we now see others follow Chen's example this AM and give you your wish. They are/will begin to openly contemplate $10 Billion in peak sales.
Best
Social
The report looks ok to me.
JL, your posts have been very helpful to me, so I'm very pleased to have paid a small portion of that back.
Go AMRN!
JL,
You want to hear from JT on the raise, but we are very unlikely to hear from the company beyond the stated found in the 8K.
But I will tell you what I think, and I hope it's worth a listen. You've been a tremendous source for the science around Vascepa and I appreciate everything you post.
Why raise this much money and why now?
Because we can. That's it. Plain and simple.
Failure to raise substantially here is a poor chess move and in fact a dereliction of the fiduciary responsibility to protect shareholders.
AMRN clearly states they have not heard back from FDA on an Adcom and can not predict the outcome of the sNDA regardless of how you or I or they feel. They can not predict if tomorrow will see a collapse of financial markets due to terrorism, natural disaster, or public uprising. They can not know the future but only make their best forecasts.
They "could" regardless of how remote the chance need to run the company for an extended amount of time without the expanded label, or under a macro distress.
This raise buys insurance or hedges by appropriate measure against these remote possibilities and in a short time frame the PPS will recover.
I hate it too, but it's the 100% right move. JT is doing the right thing.
Best
Social
BB, that would be fantastic. I hope that becomes reality.
I'm no patent attorney myself. My only interpretation of the Teva settlement is that it does make me think the others will settle too, but my only point is sooner would be better.
I actually think it's the only obstacle now to shareholder value growth and that's both for GIA or buyout strategy.
We need it done.
I agree with your assessment 100% but the remaining issue is the IP and the pending trial in Jan. I could care less about Adcom notification at this point and I fully expect a very generous label and for the approval to happen soon. In fact I think we could see the approval in July or very early August.
We need JT and our legal team to get the patent issue settled ASAP. Will we win at trial in Jan? Yes, but who needs this overhang... get it done!!!
MRC, you expect me to believe there are 2 Steven Gardino's? Both with intense dislike of Vascepa and Amarin as an investment and a penchant for posting on ihub and Seeking Alpha over believing you are that person who has indeed been critical and wrong on every aspect of this investment.
The odds on that being so seem beyond reason. But you can clear it all up by proving your identity and qualifications.
July 10th and no Adcom.
BB, I fully expect a bombshell to drop giving us approval very early. I would not be surprised by any day now.
Always appreciated Sam. Thank you.
Some really good posts this morning. Thanks BB
I'd LOVE to see JT give us a PR of no intended Adcom today while trading was open. C'MON!!!!
Today's volume so far is incredibly low.
I think the Adcom window is closed with the exception of FDA moving the PDUFA date, which they could always do. I suspect JT gets word from them of no Adcom very soon and I think it's time to begin a debate about how far in advance of Sept 28th FDA might go ahead and approve the expanded label.
Thanks
Is the math for Adcom 97 days? In other words, 55 days notice to prepare + 6 weeks post Adcom for FDA to review?
If that's correct, Monday June 24th was the window.
GIA is where the most shareholder value would be created but it would also be a much larger task than they appear ready to take on.
I would not jump to conclusions based on a few job postings. Also, they must continue the GIA work in all aspects until a deal gets done.
Really interested to see what we get tomorrow in scripts and from the FDA check in.
Hope for the best, but,,,
I think JT yesterday was pretty clear that while we all hope for decent PPS growth in the short run or even a buyout or major partnership we should mentally prepare for Q2 2020 as an important date.
The patents seem strong to me, but I'm not an expert. It does seem logical that the generic makers are simply trying to get a first mover advantage over each other but in the end want Amarin to be free to build the market that they eventually will own.
All that said, this litigation or issue is a significant overhang to any deal. How can you make a deal if you can't define the length of time you have protection with certainty.
The Adcom communication is nothing compared to knowing if you have a monopoly or not. And BTW there will not be an Adcom, just my opinion.
Also, I expect the FDA will announce much earlier than Sept 28th that the label has been expanded to be precisely equal to the patient criteria for inclusion in Reduce It
I honestly, have a hard time seeing the last couple of litigants having any motivation to settle early. They want a better deal than TEVA got and will most likely wait until the 11th hour before finally accepting equality. There is no motivation. To do otherwise. They have no pain in waiting.
I also think folks who have a voice with management, like Baker Bros should make clear the company has no debt and terms are very favorable at the moment and any additional cash needs should be solved there.
Just my thoughts after JT's talk yesterday.
BB, my job is to make money as a long investor and I see no need to mislead anyone.
I also believe calm is a reasonable state of being.
It's ok if you disagree with me. I think you have been a tremendous help to folks here I just happen to not agree with your current assessment and simply find it too paranoid.
BB, There is zero evidence the FDA has done anything out of the ordinary with regards to communicating their intentions on a potential Adcom.
My belief is we will hear something on it from JT pretty soon.
The FDA would of course maintain their options so there is no urgency for them elevate shareholder anxiety but the calendar does eventually dictate.
Hang in there man.
BB, the FDA is going to expand the label to fit the criteria of the patient population of Reduce IT. End of story.
The idea they would go beyond that and are in a hard nose negotiation or that we should get more is just not reality.
And getting more is like my 10 year old kid wanting another scoop of ice cream on top of the banana split she already can't finish.
BB, I doubt the FDA gives any thought to leverage over negotiations around the label.
In fact I believe both FDA and Amarin are on the same page. The label will be 100% aligned to the Reduce IT patient inclusion criteria. Nothing more, nothing less.
Will a BP be able to expand that in the future, maybe. But from our perspective just the Reduce It population pushes the ability to supply early on to the max as we or BP bring on additional API suppliers.
I think everything is right on target.
BB, I think this is correct.
FDA is highly likely to grant the approval well in front of Sept 28th and there will likely be an offer on the table shortly thereafter.
Any offer is going to be lowball if there are lingering patent issue(s). But that said I suspect we will get news very soon of settlement that clears that overhang.
JT clearly left Yee with that impression and has pointed to the Jan trial by saying off handed "if it gets that far". It feels like it will be ok very soon.
Lastly, a lowball offer simply gets the ball rolling.
We are in a good spot.
Don't be distracted by a game of Clue.
JT and the board have made every perfect move so far. Their track record is unbelievably positive for shareholder value.
The only 5 items that matter at the moment are,
1. NO ADCOM
2. NO EUROPEAN DEAL
3. SEPT 28 PDUFA
4. SCRIPT GROWTH
5. POTENTIAL PATENT SETTLEMENT
Everything else is noise.
BB I'm convinced. LOL.
I do believe the fact JT has held tight to Europe and has not raised money on the priority review to hire more reps starting now are very large clues.
When JT speaks next Thursday I think he will be speaking to his largest audience so far. I would be surprised by new coverage very soon.
The short was expecting/hoping for a CRL or at minimum a Standard Review with an Adcom
Now he realizes how deep a hole he's in. Very soon the window on the Adcom closes permanently. And AMRN is making moves in acquiring talent that clearly points to deal making while scripts just keep climbing and garnering great press and analyst feedback.
The PPS will go up "AFTER" options expire. Simple.
HooooRrrrraaaayyyy!!!
THe odds of Standard Review, crept up this AM IMO, with no word. Management may have been informed yesterday and if I were them having to inform us of Standard Review and an Adcom, I'd wait til after market closed going into the holiday. Give everyone 3 days to calm down.
THIS IS NOT WHAT I BELIEVE IS GOING TO HAPPEN!!
This is only saying whatever the odds were they crept up slightly this AM.
Anyone who thinks the FDA cares about patients and death rates or stats or science needs look no further than our nation's teenagers vaping themselves or the approval with no Adcom last October of yet another opiod. It's basically like handing firearms to children IMO.
Turnover of people in the agency and threats of lawsuits mean nothing to them.
This is what we are dealing with.
Count on nothing.
I believe that if an Adcom is required JT will indeed plan to use the platform to our best advantage which would be to highlight the clear differences between Vascepa and nonconforming EPA/DHA sold as supplements.
That is not fitting a narrative to believe the Adcom would be an equal opportunity for opposing views to make their case.
Look at the steady drumbeat of "let's wait for Strength trial" for confirmation type quotes since Reduce It concluded. When there are billions at stake you must expect the others to throw all they have at you.
North, I read it and it's insightful and leaves me with my original position mentally, and in share count. LOL
Nobody should misinterpret my throwing of cold water as anything against BB or anyone else. It's cautionary. It's experience.
There is nothing that could be presented to me that would change my expectation short of an announcement of FDA granting the Priority Review and no Adcom.
Do I believe all the DD? Yes. Do I believe we are deserving? YES! But deserves has ZERO to do with it.
Yes! It's like the line from War Of The Roses by Danny DeVito. "There is no winning only varying degrees of losing".
February 2020 sales will explode after new label and a the conclusion of standard review and a contentious Adcom. Expect that!!
Don't be disappointed. Be surprised if we get better news. I hope we do. I'm just making the point that all the talk of lawsuits and whether Woodcock gives a hoot is very misplaced and is raising expectations here.
Nothing wrong with HOPE... But when HOPE turns to expectation you get hurt.
BB. I believe JT. They are planning on a standard review and an adcom. Do I think that's fair? No. But everyone has had the experience of having a bad teacher, or coach, or boss. They smile and say they are on your side but use every opportunity to hold you back but stay inside the rules. They smile and promise they want the best for you and are in your corner, but anyone with that experience knows they are not.
Plan on the long, by the book road. And count on outright combat at the adcom.
That's what to expect. News tomorrow of PR and no adcom is unexpected. The board's expectation is upside down.
FDA has been in constant battle with AMRN and there is no reason why that ends with Reduce It.
The individuals at FDA do not have a care in the world about lawsuits. They don't cost them a dime. In fact watching AMRN have to pay lawyers and use up capital and time appears to give them some sort of jolly.
Even in winning AMRN loses in the eyes of the individuals.
We will hear news in the next 2 weeks but I'm starting to think standard with an Adcom, and FDA individuals could care less how fair or unfair that is.
JL, you are one of the posters I consider an expert on many topics. It's ok if you disagree with me on this. That said, trading is not about experts, or clinicians.
In order to move and more importantly sustain after a move we need shares to move from retail to institutions tightening the trading band and the ability to cover a short.
All the issues you listed are "known". The only unknowns are what will FDA approve as an expanded label exactly, and can AMRN support the demand that comes from that.
I believe funds who know and understand every aspect of this trade are indeed hung on the AMRN API availability issue.
The sooner JT addresses it showing contingency contracts that assure the supply the better.