Replies to post #184627 on Amarin Corp Plc (AMRN)

[sts66]

Aha! I was googling wrong search terms for ACC/AHA guideline updates - first link from searching "ACC/AHA focused update" is this:

https://www.ahajournals.org/doi/10.1161/CIR.0000000000000509

Methodology and Modernization

The ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) continuously reviews, updates, and modifies guideline methodology on the basis of published standards from organizations including the Institute of Medicine1,2 and on the basis of internal reevaluation. Similarly, the presentation and delivery of guidelines are reevaluated and modified on the basis of evolving technologies and other factors to facilitate optimal dissemination of information at the point of care to healthcare professionals. Given time constraints of busy healthcare providers and the need to limit text, the current guideline format delineates that each recommendation be supported by limited text (ideally, <250 words) and hyperlinks to supportive evidence summary tables. Ongoing efforts to further limit text are underway. Recognizing the importance of cost-value considerations in certain guidelines, when appropriate and feasible, an analysis of the value of a drug, device, or intervention may be performed in accordance with the ACC/AHA methodology.3

To ensure that guideline recommendations remain current, new data are reviewed on an ongoing basis, with full guideline revisions commissioned in approximately 6-year cycles. Publication of new, potentially practice-changing study results that are relevant to an existing or new drug, device, or management strategy will prompt evaluation by the Task Force, in consultation with the relevant guideline writing committee, to determine whether a focused update should be commissioned. For additional information and policies regarding guideline development, we encourage readers to consult the ACC/AHA guideline methodology manual4 and other methodology articles.5–8

Clicking on reference 4 takes you here:

http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/documents/downloadable/ucm_319826.pdf

Where this table shows minor updates (like R-IT?) take 6-9 months, major revisions take 12-18 months after two focused updates have already been written - this is great news, R-IT should be incorporated by end of 2019 at the latest, just in time for FDA approval:

7.2. Development Process

A full revision of a guideline occurs when there have been at least two previous focused updates and/or there is enough new evidence that a significant number of the recommendations need to be revised or when there is a compelling reason to change the scope or focus of an existing guideline. Revisions are managed the same as a new guideline, except for writing committee selection. One half of the previous writing committee is rotated off to allow for the inclusion of new members; however, new RWI rules must be followed so additional member changes may be required to in order to maintain the 50% free of RWI plus the chair.

Unless otherwise stated, the methodology and general operating procedures described in this manual applies to focused updates and revisions, as well as new guidelines. See Table 6.