I read the article and just wrote the gentleman a letter. Mostly asking him to be clearer in his numbers. And to help him understand better the side effects and the bigf freakin need for Telapravir.
The SVR rate is 40%, not 50%.
Rash as a side effect is not a deal killer, not if "suicidal ideation" can make it past the FDA when they approved IFN. There is also a rash from riba, quite severe for some folks and riba made it past the FDA.
with numbers like 500,000 of us trying to clear or non-responding, Telapravir is on the lips of my doctor as being approved in 2 years. The stock price can go to hell and come back between now and then, but ole Doc Scott is involved in the HALT-C trial, a Gilead trial and consults for a Vertex trial starting in Washington, so I believe the man.
I was nice to the writer of the article, but I had many disagreements with what he was writing. How much value is there in being able to bring an UND in four weeks, by itself? Even to a slow moving organization like the FDA? And then let the SOC take over for 24 weeks? Very much value, I think, just on that one aspect of Telapravir. And to shorten time from 48 to 24 weeks of SOC? More value, I believe. Even if SVR rates didn't change one whit, to rewrite protocols to include Telapravir and only 24 weeks has much value, saves money and shortens our exposure to IFN and the damage it does. Telapravir and it's rash....for me, the rash is would be welcome over what I still experience from IFN.
It's all so interesting, stock price is irrelevant now tho in my mind. The bigger picture, for those of us non-responders, Telapravir may add a great twist to the story.
Have a good one.
Ranting, wondering WIllow
Even the mother of all riba rashes doesn't come close to the rash the trial participants endured.
They really suffered and it required stopping meds for some. In addition the rash affects three times as many people taking VX as rashes affect those on SOC. Some had to be administered heavy doses of steroids just to try to control it. Rashes of this type that are confluent can be extremely dangerous. Our skin is our largest organ and the situation is a big concern. I was hospitalized once for a confluent rash and told it could kill me, so I know how serious they can be. As I recall from participants reports it took quite some time for it to resolve completely. That will trouble the FDA Im afraid. Im still optimistic that they can resolve the issue.
The fact that they approved SOC with "suicidal ideation" affecting a tiny percentage is no different than many many other drugs that have that listed in their warnings where everything and the kitchen sink is listed to avoid liability. Most all psychotropic drugs have this warning as well as sleep aids and Im sure many other types of drugs too. This is due I would think more to the fact that a large portion of the population suffers from depression and a fraction of those will have suicidal ideation regardless of what meds they are taking.
In my view there is no way the drugs will be available in "two years" to everyone. The trials coming up don't even start until summer and then it will be weill into next year before they are even done.
Thanks for the link to both Jim and Mike.
I too have watched the market closely lately and think it might be time to buy more Vertex, not sell off. I don't think shareholders know any more than the rest of us, hungering for a better treatment.
The author did make some good points in watching the numbers they use to analyze their data.
From what I've heard Kalio makes a very good point on the rash issue. It's a bit disconcerning to see some many jumping on the bandwagon as though VX950 is the Holy Grail for HCV. Makes me wonder if Pegylated Interferon received the same pandimonium when it was being tested?
If it makes tx more tolorable and increases the odds of slaying the dragon for many more than current tx regimen does, then it's great! But it still seems to fall far short of being a silver bullet. Is it really the blessing many seem to think it is if newer drugs like VX950 bring yet another round of sx's which makes tx impossible or more burdensome?
willow's quote: "Rash as a side effect is not a deal killer...Telapravir and it's rash....for me, the rash is would be welcome over what I still experience from IFN. Give me the chance to be hospitalized from a Telapravir rash, I already know the consequences of my Hep C."
Be "wery wery" careful what you wish for! ;-)
I think people have the idea it's like a "normal" rash or like something they have had that was similar. I don't think they can imagine just what you guys experienced. Words can't describe it!!
But thankfully you survived it and you are probably right now clear of this creepy virus! Even though the rash is discoraging for everyone waiting on it's approval, I am so encouraged by the fact that it looks like most reporting back are SVR. Even if it doesn't make it to market, at least you guys were cured!!
I hope you are hanging in there and things are going ok.