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Agree would be nice for mgmt to buy their own shares in support....am talking 100k block size not in 10s of thousands or less. Not stock options either, straight purchases
As its important to focus on the adcom i think there should be a lot of discussion too on possible company plans. The nov conference call will be extremly important. We need them to continue tier 2 conversion and dr conversion. Perhaps lessen rep salary pay and reward more on sales meaning increasing payout rates, drop mgmt salaries and possible changes to them.
I dont think nce had any bearing on anchor honestly...something else they are stumped about
Agreed the fda brief was in their hands for a few weeks to prepare....just surprised there were no clarifications done with fda or postponement of adcom relating to the new query.
Exactly my sentiments and relates to all my earlier comments. If they had these concerns then amrn should be notified or at least got the jist of it within the briefing document release earlier to them a few weeks ago. I question why even have the adcom if they were going after a result which is not yet known. Either mgmt were over confident or they were made to feel comfortable to proceed with adcom.
Agreed
Off topic - Am interested in seeing who is establishing new/ selling positions in the stock....every seller has a buyer and stock is holding 2 strongly. Most retail is probably out so block trades are by institutions in last two days. At a minimum amrn is worth 5-6 without anchor using azn purchase guidelines....maybe a low ball of 4-5. If jz was the main blockage to a deal then perhaps a BP would likely accumulate shares at this level for a hostile takeover. An hgsi scenario is likely.
Agreed
Agreed...we need revenue and cash savings. If amrn makes changes to business structure prior to PDUfa, we know they are not confident in snda in dec. other ideas to boost sales, a solid partner interested in EPA that believes in results of what it can offer. Élan has been interested but why not mochida, maker of epadel? They already know benefits and it's OTC in Japan. Here's their chance to get in on a global scale. Not quite sure why they didn't get involved with amrn earlier but could be an idea. Gsk is ideal but would likely wait for amrn demise and pick up pieces.
Yes changed and showed fda concern with approving for larger indication thus the question to adcom panel. Under the 10q amrn warned that this could be requested for. Bottom line is the risk to benefit analysis for them and adcom resulted in them feeling it could not be determined just yet so they safe side voted to wait. Had more focus and discussion on risk and benefits from amrn mgmt and fda, I feel adcom would have leaned towards conditional approval. Again I think worse case scenario is we get a crl in dec. We need to sell more and reduce cash burn like a traditional company without catalysts for the time being. The uphill battle, assess business and tone of mgmt during cc basically supports this. If mgmt felt there was an issue they would I think be more confident about next steps and tone would be defiant. Again, my assessment only.
The worst case scenario in the 10q happened word for word. By approving snda earlier this year fda didnt identify additional risks or studies required....they convened adcom to offer additonal view point. I still feel its a large grey area and still dont see why they couldnt approve based on safety profile pending reduce it study. Judging from fda adcom, they didnt seem to think risk to benefit analysis was worth it. Again i am not a specialist in this area but i am hoping amrn comes up with a battle plan to conserve cash and pick up sales based on marine and off label.
I doubt fda will admit breach because if it did they would be subject to liability. There is a massive grey area as to why the adcom still took place if all parties saw the briefing docs for a few weeks and could read fda question and the changes made. If you were unjustly treated your tone at the adcom and the cc would be much different in term amrn mgmt. their tone sounded like they said lets go ahead with it am sure we can get it and got burned in a sense. Again am hopefull they will resolve key issues with fda but at this point we need to focus on sales and conserving cash
No would've been nice if it was but unfortunately the type A meeting would have been nice to have before this blow up of an adcom. They would discussed changes to the fda viewpoint during this meeting (type A) and work it out vs...fda springing their thing on everyone during adcom.
Ok thank you for your input and massive contributions to this board as well. Hopefully there is a resolution. The longer this takes the more impatient folks get...they should be pounding the streets and providing guidance to us. As a long time shareholder i would like to see activity instead of silence. I think your the only one who reached out so thank you.
I thought they said margins less due to current volume costs. I think they said something in the 55-60% and could get up to 70% on greater volume discounts. Those discounts were accounting for anchor additions. If they cut reduce it, end anchor, contractual changes could increase their costs with these 4 providers. I worry about the agreements they signed with and those changes. This could all go out the window if they push offlabel like lovaza
Ok...interesting...when did amrn get the briefing doc? That would be next question because briefing doc specifically asked if we should wait for reduce it...could they not have approach fda prior to adcom and say whats this about? I just dont get why they even went through adcom as they would have seen it coming earlier than public per briefing doc?
How did joe sound on the phone and what else did you guys discuss?
This is what most of us are talking about now. If FDA changed SNDA they would've notified amrn a while back. That means amrn should have let us know about the change for the larger indication. Not quite sure what happened here. If it were not right in a sense and a surprise then cc held after adcom should have addressed it. Thats the grey area we need to find out about
Yup I mentioned triplix in my prior post....they could have done the same with amrn....far superior drug too.
Agreed...still confused about their choice to lump amrn together with some other failures without really knowing the result. Their historical approval comment for approving these types of drugs pending cvot was essentially squashed. Feel they focused more on the embarrassment issue of the study failing yet in a sense would like to see outcome. Safety profile thrown out..
It's pretty huge difference....sales stronger with anchor indication as pricing will be cheaper in insurance terms. Co pay and preferred drug status is what anchor can provide vs off label. Marine is 4m ppl vs 40mil in anchor
Agree on all points...mgmt has a lot of choices to make...that 5 min phone call did not help and I hope the next one will provide clear concise answers. They did somewhat basically say they did everything the fda asked for the indication but failed to say anything about the change in the snda specifically. I think they had those docs 2 weeks ago right? They should have said something....maybe too confident....the over confidence trails with their poor showing on the cc and no plan b.
Honestly I have no clue what happened....it seemed we were going for an indication expansion...then it became and indication expansion with a caveat to show a benefit which we won't know the outcome for 4yrs. Reading spa rules, a 13 page document I googled, I came up with information relating to bios/jesse binding comments which 98% of bears are saying it's not binding. Reading doc, they let triplix go on selling with pending outcomes I think...saw it somewhere in bd. not quite sure why they changed their minds on this one keeping in mind the safety profile. Their snda was for trig reduction I believe and then it turned into vc query or reduce it. Amarin would have had to agree to it I think and therefore we should have known about it. I may not be understanding this correctly to be honest...
I think at this point Anchor indication was what BP was after not marine especially if they have to share proceeds. I think amrn needs to get guidance from FDA on how to proceed due to trial costs and query the difficulties of the adcom. Judging from tone and no plan b response from mgmt last night, I don't think they were in close to deal terms. Partners at this point will look to seriously back them into a wall on deal terms to take advantage of them. Luckily in a sense they raised what they raised in July if not for that we would be sub one. I would work with fda, nicely or with legal team, partner and quite possibly end reduce it immediately to conserve cash for sales force and legal bills depending on which route they take. I am always hopeful élan steps up but gsk would be a perfect fit for pipeline purposes.
This was the first part..
Changes in Documented Special Protocol Assessments
As stated in the PDUFA goals for special protocol assessment and agreement,
having agreed to the design, execution, and analyses proposed in protocols reviewed under this process [i.e., carcinogenicity protocols, stability protocols, and phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim], the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.
Thus, documented special protocol assessments should be considered binding on the review division and should not be changed at any time, except as follows:
From reading FDA rules on spa, everything they agreed on was met by amrn for the indication. Not quite sure how reduce it target indication was lumped in. Amrn would have had to agree to that right in order for this to proceed? If so, why didn't they say anything prior to adcom? They had the bd prior to the meeting didn't they vs 2 days for the public? Everything I read on the FDA spa rule book also said it was binding to both parties and this excerpt below talks about what could cause a spa change in a sense. Not sure if am looking at the right thing but figured to ask.
A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.10
Élan should reconsider their options per their CEO comment a few months ago.
Excellent commentary as usual...can management begin working with them immediately or do they need to set an appointment in a few months? My worry is more on the defeated nature of their 5 minute conference call awhile ago and joes uphill battle comment. The lack of confidence in themselves and the anchor result make me believe they actually believe it and that was that. Only wish they showed more drive as some of this board have.
Agree was just posting the actual comment as someone suggested the link earlier
Here is the full commentary
Before everyone jumps out of a 13th floor window, I guess I better let folks know what is going on. One thing everyone seems to be missing is that today, the FDA announced that ANCHOR WILL be approved. In fact, it looks like the approval has basically been given.
Go back to the statement released on February 26th. It shows the sNDA was a request to expand the MARINE label in adjunct to diet only. That is all ANCHOR entails, an expansion of the label. There is nothing in the sNDA request about statins.
Now let us go to June 19th. A date of October 16th is announced for the ADCOM. In the announcement it is said again the ADCOM is for expanded approved use in adjunct to diet. Again, not a word about statins.
Now today we get the documents. We see that the only vote is on a question that asks should Vascepa be approved for co-administration with statins. Oddly enough, that is not what the original submission is for. The ADCOM is not asking about with diet only. They are asking for approval with diet , exercise , and in conjunction with statin therapy.
Hang on your hats folks, this is what it looks like is going on.
Many people questioned why the ADCOM is even necessary. I mean, there is already data and an existing drug being sold. An ADCOM just seems like a waste of time and money. The drug has been deemed very very safe with side effects being a non issue.
What if the FDA has already decided ANCHOR would be approved, but the FDA wished to expand the label to include use with a statin? I say that ANCHOR approval has been given a thumbs up, and the FDA has convened this ADCOM to see if ANCHOR can go ahead and be approved for use with statins.
The FDA wants leading doctors to look at the use of Vascepa with statins. The FDA may want to get a jump on REDUCE IT . If they can get a committee to give the existing results a going over, and okay an approval , the FDA may just expand the label to not only include ANCHOR, but also ANCHOR in a combo form.
In a way, it is the FDA covering it's rear end and expanding the label early by using a committee of doctors to give them cover in case something goes horribly wrong later. The FDA can always come back and say the indication was approved by leading experts in the field.
Now let us look at today's price action, and the hijinks of the last few days.
I say someone knows ANCHOR will be approved. They also understand this ADCOM is about a far wider label allowance than was asked for. However, they spread the lies about ANCHOR being rejected due to a bad ADCOM. That is far from the case. All the ADCOM is about is a very big expanded label. ANCHOR is going to be approved no matter what, the only question being what will the label allow.
Wall Street being Wall Street, they create a campaign to scare everyone away, and collect the shares super cheap. Imagine this scenario . The ADCOM gets an approval with 10 or 11 votes . It now is going to get an expanded label including combo therapy. How much is that worth ?
Ask all the Wall Street people buying the shares on the cheap. The conference call after the ADCOM could be a major announcement based on approval for combo therapy. That could, and very well should, be the trigger to a buy out at a very nice premium. Anyone care to speculate how fast that market will explode with approval, and a company infrastructure already in place?
On the flip side, there is a chance the ADCOM could be a negative vote. That DOES NOT, I repeat, DOES NOT mean ANCHOR will not be approved. It only means ANCHOR will be approved for the expanded label only , not for use with statins. Look for the shorts to spin that ANCHOR will not be approved due to a bad ADCOM. That is entirely untrue. This ADCOM is about a far greater label expansion than what was originally asked for.
However, the price will suffer until December 20th.
So let me sum this up. ANCHOR will be approved. The ADCOM is all about expanding the label for combo usage with statins. Wall Street is trying to confuse by saying the ADCOM is about ANCHOR approval. in truth, the ADCOM is about expanding the label for greater usage than asked for. Wall Street is grabbing super cheap shares knowing that approval is in the bag, and trying to get a HUGE return by Wednesday evening if the ADCOM gets a very positive vote,.
There is a reason Wall Street collects the money. Inside information, and the money to use the information to full advantage.
Let me add one other thing. People are screaming for JZ and company to talk about the ADCOM. They are mad because the company says they are in a quiet period. If you are this company, and you know you are days away from a possible very large expanded label, are you going to comment and possibly screw up a potential buy out ? Get real people . Could the quiet period be the simple fact a buy out is about to be triggered by a very positive vote ? Think about it a minute .
Ok thanks
Funny how a set back in pps performance and these guys come out of the wood work. If your short and bashing maintain consistency please that way people take you seriously. You may do a good job with scaring some other folks with your timing but true investors on this board are simply annoyed with these useless scare posts. Keep input relevant and state your case short or long.
This makes amrn more interesting to gsk imho..combine sales forces and sell a better drug
I agree been watching it base... Need clarity on cogs during conference call. Gl to all
Keep up the great tracking with you charts!
Anyone care to comment that the Trading action of this stock reminds me a lot about somaxon? They could get a deal but it may just be selling and sharing with no upfront cash? This company is far superior in terms of IP but downward pressure and sentiment reminds me of somaxon. I am long the stock. Just looking for insight
Buying and selling equilibrium
Agreed institutions reducing and increasing positions. For every seller there is a buyer. We wont know who unloaded or reduced but someone else picked up those shares for a great price. Its a tough enviornment with increased volatility. Funds are getting hit with redemption requests from investors so they need to sell at times too.
Your posts are helpful and provides clarity..thank you
New to the boards....anyone tracking the tap warrants?