I talked to the Principal Investigator's office at the site where I have been getting my istradefylline for the last 3-4 years. My phone message had been the first they'd heard of the FDA decision. I was told not to be disappointed yet, as it sounds like typical FDA procedure, and the drug may still be approved (eventually). I guess that means I may continue to get it, but I know a lot of you guys need it more than I do, so I want them to move it along. It reduces off time without increasing dyskinesia.
Still hopeful,
Jaye

No change in the situation at my testing center (that I know of) except that I now have to fill in a half-hourly report card for two days in the week prior to a review visit (every 4 months), showing ons, offs and dyskinesias. We did this 3-4 years ago, too, when I started participating in the trial.

distribution and /or production of KW6002- has been stopped in North America. it's share time - some are taking their goods elsewhere rather than continue trying with the FDA. Solvay has taken years to get over here even though the treatment is available outside the US. But on the other hand, do i trust any other country, other than our allies, to have completed research on the product safely and with evidence of efficacy? Does it [non-approval] have to do with the evidence[some] coming from participant diaries? People will go to great lengths sometimes, like the disgraced Korean - i think we'd all agree that was pretty far.

so who do you believe? DJM1 doesn't have to guess or choose who to believe. She had sugery to remain qualified and posted her distress. We can't let her treatment disappear without the details.

So let's post what we can and find out. Again, this is not a test. This is a real storm alert.

As Arnold says. 'I'll be back.'

paula

I was supposed to have heard last week from the nurse practitioner at the testing center, as I always do in the intervals between visits, so on Monday I called her. She responded on Tuesday. She said she'd been "dragging her feet" about calling me because she hated to give me the news. Yup, Kyowa pulled out of the whole laborious wrangle with the FDA [MY phrasing, not hers]. I have to stop taking istradefylline in July. I'll be away for a while then, so my appointment is July 30. I expect I'll be like the undead for a while after that, or maybe forever. That does it! I'm taking up yoga.

Jaye

Hello Jaye...I was wondering what sort of side effects you experienced from taking istradefylline and also if the drug really helped you?