News today shows that the announcement in mid may is only the results of the actual test.
Then the results - ONLY IF POSITIVE - then it will take 3 months to turn in request to FDA. Miraxion is on a fast track so the FDA approve it in early 08, otherwise it would take years.

It's crucial that the results be positive on the announcement but the actual drug will take a year longer to be on store shelves, for us to actually take...

It will be around a year.

This almost signed my death warrant.
I can't wait that long. I am barely hanging on as it is.
17 years symptomatic.

Scott, do you have a reference for the timeline?

I am trying to get a link as the one I got it from you have to register. As soon as I get the actual link I will post it.

I emailed the Amarin person last week and he made it sound as though it wouldn't be released for 9 months at the earliest.
I put the news about the email on HDlighthouse and on this one as "Miraxion News" as soon as I registered.

This is the actual Quote from today ---- which is a confirmation of the email I got from amarin.

"As the drug already has priority review status, the company would expect a response from FDA in early 2008, with a launch on the US market as soon
as possible after that date."

Okay, thanks. I was on the phone for an hour a couple days ago with Amarin's CEO. They are going to hit the ground running with this if they get positive results so I am not concerned about any delays on their part about moving ahead either with the NDA to the FDA or with production.

Because Miraxion has orphan drug status, the FDA will respond to their NDA within six months. It doesn't have to take that long though and assuming positive results, I think that we in the HD community need to use our political influence as citizens to let them know we are anxious for approval ASAP.

Hang on a little longer, Scott. CHDI is working hard on drug development and biomarkers to shorten clinical trials.

Hi Marsha,

Here is the complete email I got from the CEO of Amarin. It's after my little rant.
This is assuming that the results from the test are good.

3 months, mid May, until results are released. 3 months until they file the paperwork with FDA for approval, 6 to 9 months to be approved by FDA. Several months to mass produce millions of pills and get them on store shelves.

Dear Scott,

The data will be released in mid-Q2 (fiscal) which also happens to be Amarin?s Q2.

We cannot be more precise than this at the present time as the process is time-consuming and detailed.

Assuming we have good data, then we expect to file an NDA in Q3 for approval by FDA.

Best regards,

Rick Stewart, CEO
Tue Feb 13, 2007

Thanks, Scott. I was focusing on other issues in the phone call and didn't ask about a specific timeline.

Marsha,

We appreciate all your help more than you'll ever know.
thanks. We Love you.