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Hep C Discussion Forum -> Hep C News -> FDA plans to rescind Merck's MK5172 + 8742 breakthrough designation
Post Info TOPIC: FDA plans to rescind Merck's MK5172 + 8742 breakthrough designation
suziq


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FDA plans to rescind Merck's MK5172 + 8742 breakthrough designation
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Merck's SVR rates were great !!!  Not thrilled to see that FDA has taken a position to slow down competition against Gilead and AbbVie. 

Of course, I am prejudiced for Merck as I did their clinical trial and got paid to do it.  Considering my age and cirrhosis, Gilead turned me down for their clinical trials. 

I am very grateful to Merck for accepting me and for my SVR.

Hi Zlikster--not sure where Merck will be doing their approaching/current clinical trials.  Good to hear from you.



-- Edited by suziq on Monday 9th of March 2015 07:05:23 AM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
Zlikster


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Yup, i am keeping my eyes wide open on Merck's clinical trials ;)

Not that much keen on Abbvie's combos with Ritonavir...

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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
Tig


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The FDA intends to rescind the breakthrough designation of Merck's new investigational drugs. It does state their purchase of Idenix Pharmaceuticals and their plan to ramp up investigational studies later this year.This may be an excellent chance for all interested. Keep your eye open for trial opportunities and we will too.

"We do not see this affecting the development of the combo," said JPMorgan analyst Chris Schott, referring to the potential loss of the special "breakthrough" designation, which provides a gloss of specialness to drugs and can speed up an FDA review.

http://hepatitiscnewdrugs.blogspot.com/2015/02/hepatitis-c-merck-said-fda-intends-to.html#links

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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