This is the trial I am consudering:
That is nothing more than a follow up for people who have treated with generics that they got from other countries, it is not a drug trial.
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)
This study is enrolling participants by invitation only.
REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.
It's a legitimate eTrial. The results will be presented at the next AASLD.
Yes, any trial listed on the NIH site has to comply with their rules and they must have IRB approval. International trials like the REDEMPTION trials have even more requirements they must meet to be listed. They must also list each national or international health organization with authority over the protocol.
I read the listing at clinicaltrials.gov. The trual calls for 10,000 participants. That is quite a sample.
It says, "observing and collating the treatment course, safety profile, and outcomes of patients around the world"
and under 'Study population" it says "Worldwide"
The location lists Australia because that's where the data is collected.
With so many people participating it will give us a clear picture of side effects.
Below is a description of one caring wife's successful effort to import REDEMPTION generic HCV medications into the U.S. The detained package was released after the NIH listed the trial.
I am in Michigan, I was suppose to get delivery 2 weeks ago yesterday, 1/8/16 , this was the FDA response I got ...
Thank you for the information. I fully understand your situation, a serious medical condition and expensive treatment options. But, I must address your case in accordance to applicable U.S. laws and regulations.
First, the imported medication is an unapproved foreign version of an U.S. approved medication. This foreign medication does not have an U.S. approved drug application and a valid drug listing.
Secondly, there are no availability issues with the U.S. approved medication, other than its high cost.
Lastly, the purported clinical trial, REDEMPTION-3, does not appear to be a viable clinical trial in the U.S., Europe, or Australia/New Zealand, according to the clinical trial registries.
I sent that response to Andrew at fix hep c and he wrote them stating the Redemption trials was registered and sent them the link, within hours my FedEx package was released, and no response from them stating my package was released .. lol.. so it took exactly 2 weeks..
The REDEMPTION clinical trial medications seem to have passed FDA muster
Thank you for posting that.
I think you better re-read it.
That "caring wife" is my sister in law.
Her "hubby" is my brother.
Their decision to let her have the meds renews my faith in the FDA.
Glad I saw this thread. The Redemption 3 clinical trials are the real deal. Dr. James Freeman helps patients all over the world and you don't have to pay anywhere near that ridiculous price big pharma is asking for.
Gil's Tire: "Well certainly sir, I can get your tire fixed in twelve minutes ... just go ahead and write me a check for twenty thousand dollars."
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Fly: "It's just a tire, you do this all the time and $20,000 is a totally unreasonable amount of money."
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