Jomama
Here is nothing more than my best guess:
In June 2020 ECLA decided to do a trial of 1,500 ppl at high risk of Covid based on previous trials which showed Omega 3’s having direct antiviral activity and anti inflammatory benefits (reducing pro inflammatory cytokines). There theory was it would reduce infections.
Around October Dr Bhatt unblinded CardioLink-9 data and saw that his small phase 2 trial showed great promise but was too small to convince docs it worked so he contacted ECLA (because they already had a fairly big trial set up and therefore had the infrastructure to quickly set up a trial that could confirm cardioLink-9 data).
Prepare it 2 was created and PI 1 was expanded to 2,000 pts (why? I don’t know but maybe a data monitoring committee suggested it was trending but not adequately powered) on time for Dr Bhatt’s presentation at NLA. I THINK they may have had ESC in there plan from as early as February and set PI 2 target at 2,000 but the real intention was to recruit as many as possible but always planning to stop on time to have the data for ESC. PI 1 reached their goal by June 1st and closed. PI 2 is 1 month shorter so maybe they continued PI 2 recruiting for another month so they end at the same time. On clinicaltrials.Gov it is all listed as a single trial of 4 000 pts and I think ECLA views it as a single 4 arm trial. They have always been vague about the trial, the numbers and the dates - intentionally IMO. JT told me he did not know if it was PI 1 or both and said they wouldn’t get the data before anyone else. One ECLA doc said specifically on Twitter it was only PI 1 but that same doc said PI 2 only had 500 ppl enrolled and 2 weeks later we found out they had over 1,300 so ????
Some have said only PI one is embargoed and we may get PI 2 sooner. I hope that is true but Dr. Corral has been a vocal opponent of releasing data before it is peer reviewed or at least presented to colleagues first.
Amarin is going to have a large presence at ESC as they launch in Germany so it is the perfect setup to reveal PI 1&2 to a group of cardiologists on the world stage. It just seems like too perfect an opportunity for them to pass up.
I know I have made several assumptions in this scenario and before KIWI asks, no I do not have any proof that PI 2 is going to be presented, this is my best GUESS and nothing more.
It would not surprise me if the trial was simultaneously published in a peer reviewed journal on August 29.
Keep in mind the possibility the trial comes out neutral.
Only time will tell and the time is getting closer.
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