INTERCEPT IS ENDING CLINICAL TRIAL

[NYLassie]

I have been participating in Intercept's clinical trial for Ocaliva's use for the improvement of liver fibrosis. When the FDA voted against the approval of the drug last week, Intercept announced it will be discontinuing all R&D for NASH treatment. This is a grave disappointment.

[Livmar]

I agree, it is absolutely a shame the FDA voted against this drug. There are so many foods and ingredients on the market that are full of pesticides, herbicides and fungicide’s and even cancer producing which in many instances contribute towards this fatty liver epidemic. These items are approved with no issues.

Just watch one hour of television and it seems like every 5 minutes there is a commercial for a drug. If you look at the bottom of the screen, it shows all the side effects with a litany of things. How about the FDA approving OxyContin which caused the opioid epidemic.

If they want to target drugs based on side effects than be consistent. What a joke!

[GenieMan]

I am on trial with Madrigal, as long as ANY medication that’s proven works, we are lucky! And mine is supposed to come out by 2024 Fingers crossed! Don’t despair! Ask your clinic if they will recommend you to madrigal!

[NYLassie in reply to GenieMan]

I have heard good things about Madrigal. Thank you for replying.

[goldencody in reply to NYLassie]

It appears the committee also approved madrigal remestiron because their felt the benefits outweighed the risks.

[goldencody in reply to GenieMan]

I thought that drug was being fast tracked so an earlier approval was possible

[NYLassie in reply to goldencody]

It was, but the FDA kept moving the goal posts

[lusitania84]

Hmmm..... didn't they also recently shut down some other drug to treat nash? I can't remember the name of the drug but this was only a few weeks back... Amazing

[NYLassie in reply to lusitania84]

It's the same drug. The first vote last month was a committee vote. This was a general vote.

[goldencody in reply to NYLassie]

Normally the committee response is the same as the fda which is why there is hope for remestiron

[NYLassie in reply to goldencody]

It seems that Intercept is tired of fighting the FDA. I was informed by the research coordinator at the hepatology office that the trial is ending September 1. Intercept is going to focus R&D on medications targeted toward rarer liver disorders.

[goldencody]

Can you provide information as to whatvstGe you started at and ended at and how long you were on the drug

[NYLassie in reply to goldencody]

My Hepatologist's office contacted me and asked me to participate innthe clinical trial. I just finished 60 months. I am certain I have been receiving the placebo.

[lusitania84 in reply to NYLassie]

Oh is that how it works? Don't you get the opportunity to receive the drug at some point?

[NYLassie in reply to lusitania84]

If the drug were approved, the study would continue and all participants would receive the drug.

[lusitania84 in reply to NYLassie]

In end, whether approved or not, do they tell you if you were taking the placebo or the drug?

[NYLassie in reply to lusitania84]

I don't know, but the research coordinator says that after several months, it becomes apparent whether one is taking the drug ir the placebo.

[Jkf1]

So sad