Discovered all of my drugs, Zum.....originally Spironolactone but changed to Eplerenone after onset of some Gynecomastia, Carvedilol twice a day, a little dose of Crestor and now Vascepa at 4g. Top it all off with an ICD (Amiodarone....BAD!) and I'm good to go. Stopping Trials Early has been berry, berry good to me! Reduce-It is a PRIME candidate IMO. Stop It Now Amarin!
Good find, however it makes stronger my view: no early stop before the first interim analysis. (I hope you like my previous post and did not take personally :-) )
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Hard to say anything …
OND was the real (and one and only) level where the possibility of reinstatement was significant (or at least higher than at other levels). I do not think that JW or MH will overturn it (especially as JW is a member of MPC) without external influence or new, very, very … strong study result (p > 0,99999 :-) ). AMRN (maybe) will appeal one more round to JW. If it’s two round (MH) they will go to the court after that, however no way that any judge will rule against FDA in a scientific issue (max. a positive ruling regarding the “timing” and method).
But let’s assume judge will rule favor of AMRN … now, mid-September – JW’s decision around mid-Dec – MH’s mid-March 15 – submit the Complaint: mid-April 15 – judge’s ruling: mid-2017 … at this time it will be indifferent.
967th event will be around Nov 2015 – Jan 2016 (with 15%-25% eff. – or Jan 2016 – Jun 2016 with 27% - 49%.) The power should be 90% as a minimum and it is true over 19% eff. (967 @ Dec 2015 with 2,74 years avg. follow-up). The analysis will take – I guess – 2-3 months, AMRN could get recommendation, to stop the study, from DMC around Feb (19% eff.) – July 2016 (40% eff.). , so the study will be stopped (or not) 1 year before the court ruling… (But not earlier). If the study will not stopped based on interim analysis we will see the final result around end of 2017 (1612 events July 2017, result Q4 2017) within 6 months after the ruling.
I do not think R-IT’s SPA will be rescinded. Primary Endpoint is hard outcome, CVE, not surrogate end-point. Furthermore, I do not think that FDA will play the mineral oil “card” – btw: their conclusion was fair in the BD, however they did not have to raise the topic at all… - as it could be used based on lipid parameters only and the placebo CVE number could be compared with statin’s trials and I do not expect a diff. between R-IT placebo and statin trial active arm.
If R-IT is positive (likely) it will be approved.
Meanwhile, the current task is: scripts and insurance coverage (Tier 2), they have to continue R-IT, as it is the future of the company. On a long term they could not survive with MARINE and off-label ANCHOR only. Between now and mid-2016 the pps will depends on the actual script number, unless something unexpected will be happen.
NCE case: I think AMRN will win, but it will has not material effect on the company situation at that time, “just“ give additional two years till 2017. btw: maybe it will be enough if R-IT is positive (likely)
JSchaible two cents (cited by louieblouie #34191 is an excellent idea, good point, worth to try simultaneously with the necessary steps but definitely not instead of them. btw: it is a good example how to answer the question without the answer:
DR. HARRELL: I'd just appreciate a very brief statement from the division about their current thinking about conditional approval. DR. PARKS: Can you explain what you mean by conditional approval? DR. HARRELL: Approval subject to an ongoing clinical trial showing something. DR. PARKS: I think what you're referring to are the situations in which the agency can require a clinical trial to be conducted as a condition of the approval. There are four scenarios in which the agency can require such trials -- accelerated approval under subpart (h), which this application is not subject to; that was never a matter of discussion -- that's my understanding; is that correct -- during development. The other areas are deferred pediatric study, so that's obviously not going to relate to this one; the Animal Rule; and the fourth one would be under FDAAA, which is for safety reasons. So if there is a safety concern related to the product or new safety information if the product's already been approved on the market, then the agency can require a study with specific timelines that are to be met by the company to answer the question of both efficacy and safety -- well, safety for the FDAAA. For efficacy, that would be under accelerated approval. But again, that was not something that was discussed with this application.
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