Well, next time Dew Drop Inn, okay?

Think most of us will be in the stinky fart group! LOL What wonderful news!
Bill

I don't see how the all orals for all genetypes won't be approved by 2014. I am 1A and started in 2012 for three months. I just don't see 2015. Gilead has spread the net and getting more of a pool last I had heard. They have even less people in the study where I had mine for the next round. It is looking really good! You know they want to study as few people as possible and push these drugs into the market.

'll definitely be there Cat!!!

This is great news!!! Btw, in case anyone is wondering, "Breakthrough Therapy" status with Fast track designation for an NDA is advantageous compared to a drug that isn't given that status and has filed for an NDA (New Drug Application)...

What does this all mean??? It means that based on the track record of the previously approved HCV drugs, the possibility of the new drugs to be approved can happen in less than six months from now... Click here to read what the FDA says about this:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm

This is part of the official Food and Drug Administration Safety and Innovation Act (FDASIA) by Congress on these matters... Please refer to page 90 to 98 in this .pdf :

http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf

The last link is legal and binding so, That's where "the rubber meets the road."

Based on what I read so far... The FDA isn't the proper entity to protest for quicker action to approve desperately needed drugs...

These groups that are petitioning for faster approval must protest to the Secretary of Health & Human Services because the HHS secretary is the only one according to the FDASIA and it's provisions... The Director of the FDA takes order from the Secretary of HHS!!! So now we know who to yell @ according to FDASIA!!!

I hope everybody out there understands this! Because if they haven't then they have been barking up the wrong tree!!!

Victrelis (boceprevir) to treat chronic Hepatitis C
Victrelis is an important advance for patients with hepatitis C, and should have a significant impact on their lives. Victrelis was the first drug approved in its class and offers a greater chance of cure for some patients hepatitis C infection compared to previously available therapy. Patients given Victrelis with two other drugs (pegylated interferon and ribavirin) had an increased sustained virologic response (the hepatitis C virus is no longer detectable
in the patients blood). Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and
decreased mortality.
Actions to speed drug testing and review:
Victrelis was designated as a Fast Track drug and was
reviewed under the FDAs priority review program which provides for an expedited six-month review of drugs.
Safety issues: FDA concluded that the benefits of Victrelis outweighed the risk of reported side effects which include fatigue, low red blood cell count (anemia), nausea, headache and
taste distortion (dysgeusia).
Time from submission to approval: 5.9 months
First approved in: U.S. Review cycles before approval: 1
PDUFA target date met: Yes
.
Incivek (teleprevir) to treat chronic hepatitis C
Importance: Incivek is a protease inhibitor in the same class as Victrelis and was approved 10 days after Victrelis for treatment of chronic hepatitis C infection. Just like Victrelis, Incivek provides an
important new therapy for patients with chronic hepatitis C infection and offers a greater chance of cure than previously available therapies.
Actions to speed drug testing and review:
Incivek was designated as a Fast Track drug and was reviewed under the FDAs priority review program which provides for an expedited six-month review of drugs.

So that was the timeline of approvals for both Incivek and Victrelis.

We may just get our drugs approved a bit sooner being that they have been given "Breakthrough Therapy" designation!!!

And the fact that this combo from AbbVie will work for genotype 1a&1b null responders really is a Breakthrough because there are more 1a & 1b's in North America than there are geno 2's or 3's makes it even sweeter news for me and probably many in here as well besides myself!!! ;>) ;>) ;>) ;>) ;>)

And now that Daclatasvir was also given "Breakthrough Therapy" a few days ago, things are looking pretty good for everyone involved here!!! Kramer! You better come down from the Toronto area to Cat Magic's party after we're all cured!!!

Thanks Kramer for posting this great news!!!

Respectfully,
HANK

I originally typed this in my previous post in this thread and upon reading it afterwards, I noticed that I left out some important words in one or more of the sentences in this part of the previous post that reads like this:

"These groups that are petitioning for faster approval must protest to the Secretary of Health & Human Services because the HHS secretary is the only one >the missing words are below

"These groups that are petitioning for faster approval must protest to the Secretary of Health & Human Services because the HHS secretary is the only one according to the FDASIA and it's provisions, that has the power to unilaterally & expeditiously grant breakthrough therapy status as well as Accelerated approval & Priority review ... The Director of the FDA takes orders from the Secretary of HHS!!! So now we know who to yell @ according to FDASIA!!!

In other words, The Secretary can create a shortcut in order to approve these drugs even faster than the expected six months!"

This is what I meant to write. ;>) ;>) ;>)

Respectfully,
HANK

Hank, I got lost - so this means that Abbie (and Gilead I think) HAS petitioned to HHS and HAS received this status - therefore, the hurdles are lessened now as far as getting these drugs approved very quickly? "The Secretary can create a shortcut..." Does this new status mean that has been done?

How about the trials still ongoing - Abbvie is starting a Phase III to determine how many weeks are needed to eliminate the virus - at least SVR -something. That trial is short in duration as far as use of the drugs, but there is a follow-up period of ... I don't know, maybe a year. Is this new data necessary for FDA approval? I am trying to hold on to hope. Today is not one of my better days in that regard. The glass is trying to be half empty again.

Maybe some of the FDA lawmakers are positive for HCV too ! Hence, keep positive for accelerated approval !!!!

Hi Ms Magic! ;>)

I think you need to read what the official law has to say about it so. here is where to look...

This is part of the official Food and Drug Administration Safety and Innovation Act (FDASIA) by Congress on these matters... Please refer to page 90 to 98 in this .pdf :

http://www.gpo.gov/fdsys/pkg/BILLS-...

The last link is legal and binding so, That's where "the rubber meets the road."

Based on what I read so far... The FDA isn't the proper entity to protest for quicker action to approve desperately needed drugs...

And then the rest of what I posted previously.
I'm going to look back @ it also and find where it talks about the Secretary of HHS's authority to do these actions okay?
Be back in a few. ;>)

Respectfully,
HANK

Ummm, Apparently the link to the FDASIA law isn't directly linking anyone to the .pdf I'm referring to so instead, we'll just have to take the indirect route to it...

Go to this link first, then when the page opens, look to the left of the screen and if you follow those links posted on the left, look for this link titled: " Full Text of the FDASIA and click that link to the pdf. okay?
Here's the first link:

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/default.htm

Look to the left and look for "Full text of the FDASIA" and that will lead you to the pdf. Then scroll down to pages 90 thru 98 and there should be what you need to know okay?

Lots of Love,
HANK

Hank, Thx Cat for that question.

The way I understand it is that the Secretary of Human Health Service has the more so of a pull than the FDA? Kinda like the morning after pill, after the FDA approved it she stamped the age of 17 or older. She/he can add or take away provisions and thereby can create short cuts for heppers b/c the FDA takes order from the secretary of HHS?

Sounds like we need to start a petition or simply let the secretary of HHS know this is what Americans want. I am focused on grassroots efforts with women's issues.. .. ..interesting.

That's how I read it Renee. ;>)

I'm glad you did too! I only hope that all this time we heppers have all been barking up the right tree to get these drugs approved and if not, then wtf are we waiting for an invitation? :>0~

Respectfully,
HANK

If this is in fact the case and it will be fast tracked, I may put plans on hold. I have been working on getting into the 3rd phase trial with Abbvie. I am meeting with my doctor today about the results from my liver biopsy and have planned on discussing this with him. But if it is fast tracked, I may as well just wait on the release because the drive time for the trial is 2 1/2 hours one way and it will save me that trouble and expense.

Hey Kramer,
What does this mean for us Canadians? What will come first the Leafs winning the Stanley Cup or a cure???? LOL
Hugs
Debbie

Clay, I was thinking about screening for a Phase III Gilead trial (ION 3 - 8 or 12 weeks - only one 8 week arm having Riba), but I'd have to go to San Diego - 450 miles - NOT "driveable" so would have had to fly out of Vegas - take shuttles to and from that airport, pay for airfare, hotels and cabs. The center is 20 miles from the airport. It would have cost us a WHOLE lotta money that we really don't have to spend; yet, we were thinking that this is about saving my life. Now - I'll wait. And I will pray and pray hard. I'm a Geno 1, so this news about the fast tracking of the complete set of Abbvie drugs that have worked so well in trials is great great news for me (and many of you).

We can't count our chickens before they're hatched, but I'm not cirrhotic (yet), and I'm going to take the risk of waiting. At most, I'm an early stage III (two conflicting bx's in the past year so doc can't say exactly what stage - ain't that a crock of sh!t?). Now I had best clean up my act as far as eating habits and exercise - and the worst habit of all - smoking. I have to know that when the drugs do come out on the market, I didn't do anything at least between now and then to mess things up, hasten the progression of the HCV... that I did everything in my power to keep my (whatever it is) stage where it is right now.

We all have decisions to make now, those of us who aren't treating/haven't treated and maybe are late stage. If I was near a trial, within a couple hours or so of driving, I'd still go for one. But that's not the case with me. So I wait with the greatest HOPE that the FDA approves the drugs we need to stay alive a while longer.