Harvey \I love the drug but am not a fan of mgt .
First the hype " we have more offers then employee's " and who can forget "the next 90 days will be exciting ...while all along JZ cashing in to the extent of about $12m in 2012 .
As far as financial planning .... raises funds , dilutes the stock , after the pps had dropped to what ..around $6.
So after showing up for Adcom being almost totally unprepared for any flak ( yes a lot of Adcom was BS ...but you prepare for ALL scenarios ) ...after that pathetic performance they now decide to offer themselves bonus's to get the job done by June 2014.
Like I said ...Love the drug ( I take it ) but am not a fan of mgt .
Re your question. There is a push back from US dug benefit managers over the costs of these new drugs ..in particular the new Hep C drug but some are seeing implications for coverage of Ibrutinib
Note Express Scripts CMO comments ...do a Bloomberg search.
Theres also the suggestion that once in remission , prescriptions may be suspended and a " watch and wait " approach adopted. Just my take on the recent news .
I maintain a small long position
My earlier post seems to have been deleted .
Thanks for everything you and the group have done for patients and investors .
Vascepa is a safe drug and needs to be easily available all at risk , while we wait for the outcome data
I take Vascepa and maintain a small position in AMRN but I am cautious on the script outlook .
AMRN 's coupon program ends this month and they have said nothing about extending it . The consequence for patients such as myself who use Vascepa " off label " without insurance coverage is that the script will cost an additional $95 .
My wife ( a Physicians.Assistant authorized to prescribe ) has found that her "off label " patients have been denied insurance coverage for it .
GSK's Lovaza is firmly entrenched in many formularies despite being inferior in many ways to Vascepa
Anjayp ...Never but never put all your eggs in one basket ...write that on your forehead and repeat every morning
Re PCYC ...I agree with JGM. Ibrutinib will be the first choice , go to drug . The question ( and the reason I recently sold most of my position ....have owned it over 2 yrs ) is the cost of the drug . I'm concerned insurance co's will limit access to it .
I want Ibrutinib to be available to all who need it but recent comments from companies like Express Scripts indicate push back on coverage for drugs like Ibrutnib and the new Hep C drug
The MGT that bt in at 11 must be one happy bunch . When does the lock up expire ?
I've followed your posts since the CLSN days ...the fact is as far as I can tell ...you do a lot better then most on these message boards .
Do definitely scored with this one .
I'm also in ANAC and ICAD --appreciate your thoughts
Wife suggests you read up on hyperkalemia , chronic kidney disease and end stage ( kidney failure )..also mild vs severe hyperkalemia and the treatment options .
As to " GP's will prescribe it like candy " ...she wants some of whatever you are smoking ....and yes she treats hyperkalemia .
Except for severe hyperkalemia , changes in diet ( avoid banana's etc ) and exercise are first line treatment for those with CKD )
Doubts if your GP's are going to say ...hey take this drug instead of changing your diet and exercising more first ..for those with mild hyperkalemia
Just her off the cuff opinion .... Your 10m patient demand is more a drug reps fantasy then a clinicians reality
But then again you have doubled your investment so far ....so well done
Golong I have a friend who has currently completed 5 treatments of his 6 R CHOP ( going from memory ) treatments . This is the second time he has had chemo in the past 6 yrs .
I checked in with him every weekend and believe me he was one very sick guy half way through this HOWEVER ...less sick then he was doing chemo 6 yrs ago .
Treatment has improved
Given a choice between the SAE 's of the current SOC and what he has read on Ibrutinib ...he would go for Ibrubintib without question .
The question tho is the cost of Ibrutinib and whether insurance co's will cover it if they determine patient can tolerate current chemo SOC
Just my take
Re analyst estimate ....Don't think they meant by Xmas . Rlyp went from 11 to 23 since Nov 20 th ...doubt if it will double in the next 20 days . When do they submit to the FDA and expected approval date ?
( mostly OT so I hope this board doesn't mind )
Re wife ...she looks at these drugs from the pt of view of " will they help my patients and will the pharmacy include it in their formulary and will insurance pay for it "
She rates them as OMG ( oh my god ) this changes everything or does this just improve on the SOC ( standard of care )
Over the past 2 yrs there have only been 2 OMG 's. PCYC Ibrutinib and Gileads Hep C drug
TSRX , ORIS ( grafix ) ,RLYP ,ANAC etc are all improvements on SOC but not to her OMG discoveries and she's has questions re to what extent insurance would cover etc.
Insurance coverage concerns are now also appearing re Ibrutinib and Gileads Hep C drug
Anyway these are early days for RLYP ...analyst upgrades and a great chart ...what could go wrong ?
My biggest position has always been FBIOX ...I'm fairly conservative ...but also have small positions in HALO , CUR , ACAD ....
What do you think of CHTP ? ...I follow the Baker Bros to some extent .
I still have a small position in AMRN , which we can discuss on that board sometime if you like
Good to see you are doing well
Appreciate all you do keeping us current with PCYC .. Not doubt Ibruitinib is the wonder drug however the CMO of Express Scripts seems to be questioning how widely it will be prescribed because of the cost of the drug ( Bloomberg article )
Any comments ?
Congrats Golong .. Wedbush analyst looks like she knows her stuff . My wife ( dialysis ) remains a little skeptical and she was right on AFFY. She thinks its an improvement but maybe over hyped per end use.
Since you have a double ....maybe ...well you know the rest
Re test results available in 2010 . I believe you are talking about the ACCORD-Lipid trial 2010. The median TG level in that trial was 162 .....Not in the Anchor indication of 200-500.
There was no benefit seen in this group HOWEVER in the sub group of patients with both TG's over 200 and HDL cholesterol under 40 , there was a 28% reduction in CVD risk
So ...most benefit IMHO will be seen in this sub group ..high TG /low HDL ...the question is " How much benefit once patients are at optimal Statin therapy " ( which is defined as getting LDL cholesterol to 100 )
This we won't know until we get some Reduce it trial data
The Anchor Trial was not designed to measure reduction in CV events ...it only lasted 12 weeks I believe....so how could it be "indicative of the efficacy to reduce CV events " ?.....it measured the efficacy of lowering high TG's for those on Statin therapy WITHOUT raising LDL. cholesterol
Would be nice but I suspect they have just approved the label change ( re nursing mothers I believe ) ...approval of the Anchor indication any time soon , still looks like a real long shot IMHO ...altho I think they should . Vascepa is a very safe drug and Doctors and patients should have some choice here
We need to have 967 events ( 60% of the 1,612 events expected by Dec 2017 , if Vascepa has no effect ) before we have an interim analysis ......that would be about Dec 2015.
So , If Vascepa IS having the effect we expect , it will take longer to get to 967 events and therefore the interim analysis will happen well after Dec 2015.
Is that correct
I think they will do everything they can to survive until the interim data analysis ( 900 events ) expected late 2015 .
They have I believe about $200m in cash. Mgt can cut salaries by 50% in exchange for options etc . They can talk to the FDA about ending enrollment at 7,000 patients ( I'm not an expert here but I believe you can get great data from 7,000 patients instead of the 8,000 planned on) and so on .
There are things they can do to conserve cash.
When the interim data is released , if Vascepa is working as we hope , event lines between the two groups will have diverged enough to hopefully be stat significant ....at that pt we should know if we really have an important drug or just expensive fish oil.
If Vascepa is then showing strong clinical benefit , Amarin will be in a very powerful position to negotiate partnership deals.
Good post ...Reduce It answers it all ...which is why it MUST continue . If Reduce It shows stat sig clinical benefit ...particularly in "hard " events like heart attacks it will be a huge game changer .. If not ..well then Vascepa is still a good drug for those with very high TG's and high LDL ...but thats a small market and not worth owning AMRN for.
The issues some have with Jelis is that it was open labeled , 58% postmenopausal Japanese women and LDL lowering was not optimized ( ie statin dose not strong enough ).
By contrast Reduce it is double blinded , over 60% American , LDL levels under 100 and TG's over 200 --its a much stronger trial.
My only concern is that I hope the FDA doesn't use the mineral oil (placebo ) issue to question the results if the trial is successfull
Well its nice of you to say I may "share decent information " but honestly I did not expect the Adcom to deny Anchor . The opinions I had ...even from a Prof /Scientist in the field at UCSF was that they would approve simply because it was a SAFE drug that MAY show clinical benefit...there was no downside .
Where I agree with Siggy is "that lack of direct reference to lowering TG's in the new guidelines " I only see reference to treating very high TG's NOT TG's between 200-500.....so on balance I see the new guidelines as unfortunately a negative ...at least until we get some Reduce it data
Thanks Cincy ...sorry I don't know anything about the Co.
OT HALO and PCYC are my biggest B Brothers holdings plus some ACAD