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
Oh common on now ..I wanted to tell the EM doc that Butlers told me to do it ...take 200x 4 Ibuprofen
Actually i was going to write " What ...I just took 200 x 4 .. and NOW you tell me .etc " : )
butters ...not sure if I'm following your line ...but really , if you are really "at risk " ...family history , stents , diagnosed CAD ...go with RX grade Vascepa if you can get a scrip and its priced reasonably with coupons .
Frankly DS versions at less then 4 gms a day are questionable .
Besides ..according to the AHA ...we won't know if Vasepa really works until we see Outcome data
How do you know BBrothers took a 19.9% interest in MRTX. Please confirm
I follow them
Butters ...If Reduce it shows a reduction in heart attacks ...even if the interim analysis after about 900 events ( expected late 2015 ) shows a stat sig divergence in event lines ...Vascepa will be huge
No one , in my experience , likes Statins . Muscle cramping and short term memory loss are real issues as is concern about increased risk of cataracts and diabetes .
Vascepa is BY FAR the easiest to tolerate of all the lipid altering drugs ... IF it demonstrates a reduction in hard events ( heart attacks etc ) ...it will be huge ...which is why I still own the stock .
Did I mention IF it demonstrates ....you get the picture
I have to say I agree with you on your original post ( JL is a real MD IMHO by the way ) ...anyway ...what stunned me about the new AHA guidelines is their total reliance on Statins and lowering LDL ...based on the outcome trials they reviewed.
The Lipid Assoc ( not correct term ) is not buying into it but the IMHO Cardiologists will follow the AHA line ...it provides "cover "
Re Shortfish ..hey give him credit for cataloging so many shorts ( who unfortunately ..often for the wrong reasons ...have been right )
XXX well thats fuuny ...I have high TG's ( if I'm not on max dose statins ) and a friend is currently under going chemo for the type of cancer that PCYC stops ( or at least reduces ) .....so from a front line experience ...they are worlds apart
Consider yourself blessed if all you have to worry about is high TG's