Replies to post #222144 on Biotech Values

[linhdtu]

you are spot on about personality and ego involvement. AF I've known for yrs ,going back to his thestreet.com days ,is a lightweight in bio knowledge.

While he is no good in data analysis, he is quite useful in bringing into the spotlight the financial and PR shenanigans of cheap price stocks and thus earned himself a (not deserved notoriety imo) among those retailers who love gambling with penny stocks .

As far as Matt Herper, in this case I do have to agree with you. He was sceptical about V top line already and yesterday imo was just digging deep enough to validate his preconceived earlier biases.

In terms of human foibles what these two did yesterday was nothing new to me. I can't remember whose quote is was ,but imo it was quite perceptive about human nature. "Scientific knowledge advances one death at a time".

Just remember how hard and how long it was for radical mastectomy to be dethroned or better yet how difficult for the bacterial diagnosis of ulcers to become mainstream.

thank you for your contribution to this forum btw

[rfj1862]

how these were addressed with different prespecified analyses

Note that I misstated something here: The log-transformed CRP was prespecified, the LDL-C analysis was post-hoc.

[DewDiligence]

…Which…we know is not true, as the log-transform analysis [on hsCRP] was prespecified.

Page 7 of the trial protocol says:

https://www.nejm.org/doi/suppl/10.1056/NEJMoa1812792/suppl_file/nejmoa1812792_protocol.pdf

ANALYSIS OF TERTIARY ENDPOINTS

The following clinical events that are positively adjudicated by the Clinical Endpoint Committee (CEC) will be analyzed as tertiary endpoints for the ITT Population:

• Composite of total mortality, or new congestive heart failure (CHF)
• Composite of CV death, or new CHF
• Sudden cardiac death
• Peripheral artery disease (PAD)
• Atrial fibrillation, or atrial flutter

These tertiary endpoints will be analysed similarly as for the primary composite endpoint. In addition, the following will be analysed as tertiary endpoints for the ITT Population:

• Relationship between on-treatment high-sensitivity C-reactive protein (hsCRP) and the primary and key secondary endpoints
• Relationship between on-treatment serum eicosapentaenoic acid (EPA) and the primary and key secondary endpoints

To assess the relationship between on-treatment hsCRP and the primary and key secondary endpoints, subgroup analyses will be carried out as done for the ITT population for patients grouped according to values greater or equal to or less than 2 mg/dL at baseline and at 2 years.

The above reads as though the raw hsCRP numbers are the ones to be used in the prespecified analysis, so it appears that the excerpt from Nissen that you quoted is truthful.

[jbog]

Amarin announced primary results from Vascepa cardiovascular outcomes trial

Amarin announced the primary results from the Vascepa cardiovascular outcomes trial, REDUCE-IT, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. Cardiovascular benefits appeared not to be influenced significantly by triglyceride levels at baseline or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline.

REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reduction on top of statin therapy in a major cardiovascular outcomes trial. REDUCE-IT studied Vascepa 4 grams/day as compared to placebo over a median follow-up time of 4.9 years. The REDUCE-IT study was designed under a special protocol assessment agreement with the U.S. Food and Drug Administration.

Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019. Vascepa is a low-cost drug. The majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9 for a 90-day supply prescription of Vascepa.

Read more at:
https://thefly.com/landingPageNews.php?id=2821895

[DewDiligence]

(AMRN)—As far as Herper interviewing people for his article: Did they have access to the data? …I can get any answer I want simply by changing how I phrase the question.

Herper addresses this in the following tweet series:

Media embargoes! This is the most common complaint about my $AMRN stories. So here's is something all biotech investors should know.

Most healthcare journalists are offered what is called a media embargo by The New England Journal of Medicine and major medical meetings. 1/6 https://t.co/epjImTvQhM

— Matthew Herper (@matthewherper) November 21, 2018