Produodopa Miracle

[Farooqji]

Video shows drug's 'life-changing' effect on Parkinson's patient

bbc.co.uk/news/articles/cd1...

[Gioc]

it was time!

After 50 years of C/L and fluctuations finally some improvement!

Even a formulation of levodopa that is more persistent in the blood than normal levodopa would be desirable in the absence or waiting for the miracle , very expensive drug (-mab antibody ).

healthunlocked.com/cure-par...

parkinson.it/farmaci/sicure...

[LagLag37 in reply to Gioc]

How could someone from the U.S. obtain something like this? 🥊

[Juliegrace in reply to LagLag37]

Not until it’s approved by the FDA. No idea why they haven’t approved it yet.

[parkylot]

I follow your posts faithfully.

I'm looking to improve my condition, like all of us, you'd come up with the answer.

Probably costs a fortune

How is it taken

Thanks Farooqji

Joey

[Rupa88 in reply to parkylot]

it is like insulin pump

Subcutaneous continuous injection

Approved in Canada, Australia, not in US yet

[parkylot in reply to Rupa88]

Thanks

[cjCardio53]

Bring it on..the pump and the med! It's inspiring..giddie up!

[Jana86]

The situation in the US is very troubling. AbbVie completed extensive phase III trials two years ago and the FDA has refused to license the treatment here twice and for no apparent reason. It is now licensed in 38 countries but not the US. The latest published report in January of this year cites the FDA found an issue of non-compliance in a third party vendor that has no role in producing either the pump or the infusion. The FDA also refused to license a Japanese manufacturer offering a similar device, citing no reason at all. Is the FDA manipulating the market to delay introduction of a treatment that will compete with DBS? There are thousands of people with Parkinson's whose quality of life will be better with this device. Time to make a ruckus??

[Canddy in reply to Jana86]

Yes! Time to make a ruckus! First step? I called the company a few months back and they could not give me a timeline regarding FDA approval. How do we go about making our voices heard?

[Jana86 in reply to Canddy]

Well, I am writing to my Senators today and to ask if their staff will inquire of the FDA why PWP in 38 other countries have this treatment and we do not. The last and very successful Phase Three trial was completed two years ago. My neuro has been telling me she can only offer DBS to deal with my erratic uptake of CL and, for two years, I have said I want to wait for this subcutaneous pump but I can't wait much longer. My DBS is scheduled for Sept 19. I have to have brain surgery because why? At least provide a reason,

[Canddy in reply to Jana86]

I am contacting my Senators as well. And I have not scheduled anything but have been thinking about DBS as an option more than I ever have before.

The lack of approval for this product flies in the face of the recently signed into law:

National Plan to End Parkinson's Act

which I will bring up when I contact my Senators.

[Jana86 in reply to Canddy]

HHS has the responsibility to set up the planning process but I can't find the specific office that has been assigned to support it. I am asking the Senate staff for help to identify the right HHS office to contact.

[Canddy in reply to Jana86]

Please post here when you find out I will do some digging as well.

[Biscuit61 in reply to Jana86]

Hi is it licensed to use in the UK thanks

[JeanieBeanie in reply to Biscuit61]

It is in the Uk. I believe 1000 patients have been trialled on it. We asked my husbands neurologist about it last February but he didn't seem to know about it . If you click on the link it tells you the hospital and the patient is from Derby.

[Biscuit61 in reply to JeanieBeanie]

Thanks for info !!

[Canddy in reply to Biscuit61]

Yes it is in the UK but I am located in the US - we NEED this drug/device approved in the US! Jana 86 - I had the exact same thought as you regarding DBS. Is the DBS industry (literally) lobbying against approval of the treatment?

[Canddy in reply to Jana86]

Perhaps AbbVie was not granted FDA approval in the US in retaliation for this:

accountable.us/pharma-giant...

I am not usually a conspiracy theorist, but something stinks about this situation...

[Canddy in reply to Canddy]

The headline for the link should read

Pharma Giant AbbVie Brings in Billions While Opposing Biden Administration Program To Bring Down Costs for Consumer