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.
HCV Prison population
The best report on HCV demographics in the USA that I have seen is the 2013 Milliman report - http://us.milliman.com/uploadedFiles/insight/2013/convergence-of-risk-and-opportunity.pdf
They estimated a prison population of 450,000.
They came to this estimate simply by taking the midpoint of prevalence estimates from the credible studies of prisons they could find. That midpoint was 30%.
GILD buyout candidate -
Well, this guy thinks Pfizer.
http://seekingalpha.com/article/4006202-never-guess-biggest-risk-facing-gilead-investors
Given GILD's languishing share price,
but impressive cash flow, as well as cash on hand, who do you think might be a buyer?
I don't have any relevant facts, but a quick google turned this site up - http://www.hcvinprison.org/
The tongue-in-cheek is clearly give away by the opening sentence - "As the CEO of Mylan, maker of the world-famous EpiPen, it gives me great pleasure to address you, via email from an undisclosed location, concerning the pricing of our product".
Slightly OT short reporting question -
You can easily find who are the institutional holders of a stock, but can you find who are the large shorts in a particular stock? I know every two weeks you get the total short position by each security, but where can you find who exactly is doing the shorting?
If this isn't publicly available it would seem to be a flaw in reporting requirements and to give the shorts an inappropriate advantage.
'Poisoning the well' in the Street ZIOP article
In the first sentence it says a patient died from a brain bleed "soon" after receiving the ZIOP drug. The word "soon' helps create the picture of a causal link between death and drug.
At the end of the next paragraph, we learn that the patient died fifteen days after the injection. Soon means 'any minute' or 'any day,' not fifteen days. There is no journalistic integrity in an article written like that.
ZIOP question - What does it own solely?
What of its technologies does it own 100% of? What is not Intrexon's?
Thanks in advance?
Re:XNR, City of Hope is 2 miles away.
Here is the 2016 Medicare Trustees report -
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2016.pdf
We should know whether the IPAP will be triggered today, as the Trustees report is due out today.
When released, it will be here - https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/index.html?redirect=/reportstrustfunds/
Medicare spending has been coming in far less than originally projected by the CMS.
http://www.rwjf.org/en/library/research/2016/06/the-widespread-slowdown-in-health-spending-growth-implications-f.html?cq_ck=1466182688800
I don't know much about the IPAP process, or where they get their targets, but Medicare as a whole is performing rather well.
As far as dialysis, the program is large because it is not age dependent. Medicare covers anyone who has ESRD, End Stage Renal Dialysis.
Second baby gets Cellectis 'designer' cells to clear leukemia
http://in.reuters.com/article/us-health-celltherapy-idINKCN0XX1F7?feedType=RSS&feedName=health&utm_source=Twitter&utm_medium=Social&utm_campaign=Feed%3A+reuters%2FINhealth+%28News+%2F+IN+%2F+Health%29
Express Scripts and the Pinocchio award -
When Express Scripts contracted with AbbVIe for V-Pak they promised to open up access to HCV patients and not limit coverage to the sickest.
http://lab.express-scripts.com/lab/insights/specialty-medications/expanding-access-to-a-hep-c-cure
What porfound dishonesty on their part.
HCV treatments and side-effects
I remember hearing Dr. Gish, one of the top hepatologists, talking after Sovaldi was introduced. He said something like "We went from our staff being consumed with managing side-effects to our staff being consumed with managing insurance approvals."
I don't think you can underestimate how much physicians will try and avoid having their staff overwhelemed with managing side-effects. Early on, Gilead recognized both sides of that issue and in one of their conference calls they acknowledged that one, not the only, of their reasons for reducing price was to remove the insurance burden from prescribing physicians.
Gilead/Merck Patent trial question
After the jury returned their small award for past revenues last month, there was supposed to be a relatively quick decision about the award of a percentage of future revenues, but there has been no news for weeks. What gives? Negotiations between Merck/Gilead suspending the next step?
Thanks Dew and Jim.
Would I be wrong then and just saying 3 in the last 20 years, given that Viagra was rather unintended.
Pfizer R&D question?
What blockbuster has Pfizer developed in-house in the last two decades? Remember Lipitor was developed by Parke-DAvis and acquired in the Warner-Lambert takeover.
HCV Sales -
JohnWayne responded to a question of mine and indicated that Kaiser-Permanente is also not included. (Neither uses a traditional pharmacy, but buys in bulk and dispenses in-house.) Kaiser favors Harvoni and Sovaldi and is not throwing up roadblocks to treatment.
CBLI Update -
Cleveland BioLabs Provides Update on pre-EUA Review of Entolimod as Radiation Countermeasure
Buffalo, NY – March 16, 2016 – Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced an update on the regulatory review of its pre-Emergency Use Authorization (pre-EUA) submission for entolimod as a radiation countermeasure following the receipt of minutes from a recent meeting with the U.S. Food and Drug Administration (FDA).
As part of the company’s response to pre-EUA review comments received from the FDA, a meeting was held with the Agency to discuss various aspects of entolimod manufacturing. At this meeting, and subsequently confirmed by the FDA’s official minutes of the meeting, it was determined that an in vivo study will be necessary to establish bio-comparability between the entolimod drug formulation proposed for use under the pre-EUA and the drug formulation used in previously conducted preclinical and clinical studies. The FDA indicated that further review of the pre EUA dossier would not proceed until these bio-comparability data have been evaluated by the Agency. The design of the bio-comparability study is currently in development and will need to be agreed upon with the FDA before the study is executed.
Yakov Kogan, PhD, MBA, Chief Executive Officer of Cleveland BioLabs, commented, “While this FDA request has temporarily slowed our progress, we remain fully committed to the pursuit of pre EUA status and commercialization for entolimod. We will provide further updates regarding the estimated timing for performance and reporting of the study once the design is finalized. Our goals are to satisfy the FDA’s request and facilitate continued regulatory review of the pre-EUA dossier for entolimod as soon as possible.”
Thanks JohnWayne. So, without the VA and Kaiser and other similar systems, we may well be missing a lot. Just between the VA and Kaiser there were around 350,000 with HCV in 2013.
Well, the NRx for Sovaldi and Harvoni are up, but the 10% drop in Sovaldi TRx is troubling. Overall though, a mixed weekly report in the midst of a downward trend.
Still, I would love to get an answer to the question - Does IMS data include closed systems, e.g. the VA or Kaiser-Permanente? These systems buy in bulk and dispense internally.
Does IMS include data from closed systems, e.g. the VA or Kaiser?
I suspect that the VA has simply concluded, given the discounted price they are giving, that it is cheaper to cure everyone now than pay for treating the disease progression.
Merck Earnings transcript and headlines of 'price war'
I read the transcript. Three different analysts tried to get Merck to describe how they would approach pricing. Merck gave various answers, but none of them presaged a 'price war.' What they did telegraph is a focus on the specific areas where Zepatier has an advantage, e.g. ESRD patients.
http://seekingalpha.com/article/3861416-mercks-mrk-ceo-ken-frazier-q4-2015-results-earnings-call-transcript?all=true&find=merck
Zepatier should not be given to patients with..
"Zepatier should not be given to patients with moderate or severe liver impairment." I haven't seen much comment on this Statement in the FDA press release, but I believe this is far more of an issue than the RAV testing. I have never seen an accurate accounting of HCV patients by stage, but I would guess that roughly half have moderate to severe impairment and Zepatier is ruled out for them. Further, for those with no or mild liver impairment Gilead has the possibility of an 8 week treatment, that is for those with no or minor impairment that insurance companies will cover.
The Grinch stole my NDA!
Valeant may soon be available.
Treatment naive and non-cirrhotic are the easiest and with only 91% SVR for GT1, why would they even advance to further testing?
Sovaldi and cardiac issues -
This report is based on three cases - two of which were also on daclatasvir and one of whom was on amiadarone, which is already contraindicated with Sovaldi. In sum, this problem may relate to Sovaldi and it may relate to another drug.
613,000 people have to date taken Sovaldi and there have been 9 case reports including these three.
Tempest in a tea cup or mountain out of a mole hill?
Indictment of animal models from Turkish Gastroenterology Journal
http://www.turkjgastroenterol.org/sayilar/288/buyuk/From%20the%20Editor%20%20y.pdf
I chatted with a pharmacist at a Walgreen's next to a major hepatology center that dispenses a lot of anti-HCv meds. She said it is a fight to get almost every new HCV med approved. A fault is almost always found in the initial paperwork. An additional test has to be ordered. More paperwork from the doc is needed. Delay, delay, delay is the name of the game.
ESRX CC -
Did their promise to open up access to all HCV patients regardless of disease stage come up in the Q and A?
Sovaldi/Harvoni
Given GT 1 is 70% of the USA population and Harvoni is only approved for GT1, you could expect that 70% of total hcv sales would be Harvoni and 30% Sovaldi for the other genotypes, which would be 970 Sovaldi rx instead of just 692 in the recent quarter.
I wonder if the recent numbers are closer to what should be expected and that the prior weakness of Sovaldi is due to insurers making it more difficult for the non-GT1 genotypes, perhaps citing less effective cure rates.
Re Jefferies odd data -
A reasonable estimate of cirrhotics among the HCV population is 30%.
http://onlinelibrary.wiley.com/doi/10.1002/cld.3/pdf
And I'm sure you won't be able to find a single hepatologist who would prescribe Viekira for any cirrhotic, be they Child-Pugh A, B, or C.
Misstatements -
The original FDA press release had language something like - 'most of the deaths occurred in patients with advanced liver disease'. Advanced liver disease means cirrhosis and if most occurred for that condition, others occurred for less severe states. The current FDA press release has been edited and is clear that the deaths were in patients with cirrhosis.
Given they changed their description, I changed.
Healthy liver = F0
HCV causes liver inflammation and scarring, leading to fibrosis and cirrhosis. A healthy liver would have no inflammation and scarring and would be classified F0, a category for which few insurers pay for treatment. Beyond, few HCV sufferers have an F0 score simply because they have had HCV for decades and the inflammation and scarring worsens over time.
The recent cases of death and need for transplantation due to Viekira happened in week one through 4 of treatment. To cure HCV with Viekira in a non-cirrhotic patient, you need 3 to 12 times the amount of Viekira that led to death.
While the FDA chose to not do anything more stringent with the Viekira label, physicians on their own may well decide, being generally conservative, that Viekira is not a risk they wish to inflict on their patients.
Another SIRF report on Valeant
http://sirf-online.org/2015/10/25/the-kings-gambit-accepted-the-annals-of-fraud/
I have not seen anything from the FDA saying all of the 26 patients affected were cirrhotics. They only said most were. Unfortunately, they didn't identify the rest.
Also, I don't know what you mean by healthy livers apart from HCV. The vast majority of HCV patients have had the virus for decades an even if they do not have cirrhosis, it is an extraordinary stretch to say they have healthy livers, which is exactly why the patient deaths from Viekira are a concern for the whole population.