Why is there so much concern for the placebo effect? Both measures were compared to baseline.
Anchor sought to show non-inferiority when combined with statins LDL-C
I cannot seem to post the entire analysis.....
I have read the entire document and these are my conclusions. Hopefully Yahoo will allow me to past the entire thing this time:
Primary objective: ANCHOR’s primary objective was to determine the efficacy of AMR101 2g
daily and 4g daily, compared to placebo, in lowering fasting TG levels in patients at high risk for
cardiovascular disease and with fasting TG levels ≥ 200 mg/dL and
* Only Jelis actually used purified EPA and it is the only study to demonstrate cardiovascular benefit
* All other studies use DHA / EPA combinations
* Accord and AIM-HIGH don't even look at the same population of patients, (Accord : Type II diabetic, 164mg/dl ave TG)(AIM-HIGH TG=161 mg/DL ave) Anchor uses TG 259mg/DL on average.
* The only relevant study to either support or refute EPA is Jelis.
The patients were already on statin at baseline? The lead in period removed other triglyceride lowering drugs. The question is does vas lower triglycerides below what is already observed with statin therapy. The major issue is to determine if vas interferes with statin therapy in regard to LDL -C at a greater level that the non-inferiority level of +6.0%. Compared to baseline vas only increased LDL -C by +1.5%. Compared to placebo vas lowered LDL -C by -6.5%.
I do not agree if you look at the table on page one you see that the change in TG for Vas is -17.5 % compared to baseline and -21.5% when compared to placebo. Baseline measurements were done before any Vas or placebo were given, Just because the difference between Vas and placebo treatment groups "may" be exaggerated that does not mean the difference between Vas and its baseline measurements are not real. They are.
Why is there so much concern for the placebo effect? Both measures were compared to baseline. Anchor sought to show non-inferiority when combined with statins LDL-C
Biotech is getting hammered all the way around. Its been hammered all week. Guess this was the easiest sector to manipulate for the big boys. I bought some calls today to take advantage.
I believe I will join you Al. I have not learned anything of value from this board in some time. A johns comments below demonstrate the vast majority of posts here these days. The stock will turn around when it's time. I believe in this product and Al Mann.
I agree with you 100%, thought I question how well those to buy and sell do on average?
Take "our" situation for instance. Had we sold at 8.00 (best case and we would have likely sold at 7.50 or lower) we would have paid 30% in taxes for those gains and waited for the best opportunity to get back in.
As its impossible outside of dumb luck we probably would have assumed that 6.35 was a good entry point to get back in and...... as of today we would be down an additional 22%.
Outside any material information to the contrary I am holding for the ultimate goal and once I sell I won't look back.
Its pathetic that this system is rigged so badly and apparently there is nothing we can do about it.
At some point they will cover and go long..... its wrong and unfair that we had the intelligence to get in early and they get to cheat their way in.
The fundamentals are still there. Ultimately the success is still there we just have to endure this criminal manipulation.
Deerfield financing was necessary to execute NDA build out manufacturing, which WILL be considered by FDA for approval, and move forward towards possible launch. If their plan was to sit back and hope / wait for partnership deal before executing their business plan then they would have been foolish. They are right on track and are in a much stronger negotiating position by executing their business plan.
I think it's quite clear kev is speculating. Comments he posted from sanofi are very compelling. No way to know the outcome but based on those comments one has to believe MNKD is on their radar screen
There are many possibilities two of which include competition and a desire to get in first and there is nothing preventing a partnership agreement in which payments and finalization are contingent on FDA approval. This would be much like thar tranche requirements in place with Deerfield.
Those were the good old days!! I now have more than half my screen on ignore. Our day will come. Keep your eyes on the horizon.
At some point you have to do your DD and make an educated guess. Especially in Biotech there is far too much manipulation but also huge upside.
This stock will have its day...... its still up 133% for the year.... it will be up 200% EOY in my opinion.
Uncletizz has been shorting this stock since 1.85 and he still isn't even close to even. I'm long since 2.00 + lots of 2.00 calls. Worst I can do is break even....... he will never dig out of his hole and with news he will get buried even deeper.