RE:RE:where is the great francine in all thisSorry for the delay in my response, I was very busy this week.
Obsiously not really happy with the situation like every shareholder.
My early retirement was delayed for few weeks ;) All the haters and shorts are all over this board, but please don't listen to them.
I didn't spoke witht the management, but I spoke with some shareholders and brokers.
They have around $20M in cash: NO CASH problem in the short term !
Here is the situation: TG were reduced by 30.5% (12 weeks) and 36.7% (26 weeks) with NO AE (adverse events). Those results are a SLAM DUNK. FDA won't ignore a drug that reduce TG by over 36% in 26 weeks. Those results are 100% in line with the COLT Study which were with 2gr/4gr (8 weeks) 21.6%/23.3%. FDA will review all the data in this context. This drug WORKS.
PLACEBO PROBLEM: The placebo number is Capre/placebo 2.5/1 which represent 70 patients on placebo vs around 172 patients on Capre. The problem is specific to 5 sites which represent around 36% or 25 patients on placebo. THIS IS NOT a significant number.
As per COLT study, the placebo (N=29) was +2.5% after 4 weeks vs Trilogy 1 at -27.5% which doesn't make any sens. If the remaining balance is around -5% this means that de 25 patients are aver - 50% TG reduction for 4 weeks. In any study the FDA will accept a placebo with this kind of results.
ROOT CAUSE : We can speculate on various explanations (raw material contamination, manipulation error, falsification, other lipid medication, etc etc), the only thing we are sure is that its not the act of GOD and its would founded to be true, this mean that cornstarch is a better drug than Amarin.
NEXT STEPS : Let's be positive, management will find the explanation and T2 will give us the same great numbers, secondary end points will be meet and in March and glucose reduction will be confirmed.
WORST CASE : what is the worst case, they don't find any explanation!? FDA agree that it does make any sense and they Acasti is required to do a 4 weeks trial 1:1 placebo:Capree with around 50 patients. Acasti T1 & T2 only required to hit -11% placebo reduction to have the 20% TG reduction.
Lets be honest, the FDA won't throw to the basket the entire study. End of story.
GLTA