May not be a universal usage, but amongst HCV patients, rescue refers to anti-anemia drugs, e.g. epogen.
I have only hearsay from AASLD, but the hearsay is that FDA officials do not want epogen in Phase III HCV trials. They apparently want to evaluate the addition of one drug to SoC, not two.
A principal side effect of boceprevir seems to be anemia and epogen was used in their Phase II trials. Vertex did not use epogen for patients suffering anemia in Phase II. Patients with anemia in the Telaprevir trials either suffered through or quit. Patients with anemia in the bocperevir trials were "rescued" with epogen.
Thanks for refreshing my memory.
Certainly, the FDA has had a lot of input into the Phase III design, as would be expected.
I don't think though that the trial design preempts, as you appear to imply, a filing based on Prove 3. I still hold out a good possibility of such a filing early in 09.
As far as input into Phase III trial design, I find it far more interesting that there is significant scuttlebut that the FDA will not allow rescue drugs in the boceprevir Phase III trials. If that is true, that is quite a setback for boceprevir.
I remember that too. I am not sure what Dew is doing here. Sometimes he has some really good comments and insights, than again he does not make much sense? Maybe he is long and short in the same time, that would explain that I get the feeling he has a split personality disorder....
Sorry Dew I am just kidding, or do I?
Didn't you post an opinion about the liklihood of telaprevir being approved based on Prove 3 results? I seem to recall your post indicated that approval was a slam dunk if telaprevir achieved better than 50% SVR in 48 weeks, but they actually achieved it in 24 weeks?
Is my memory correct?
So you are thinking $14,400 per treatment, assuming 12 weeks on drug? Also, you quote the price as per week - are you saying that if VRTX goes with 8 weeks instead, that the revenue goes down to $9,600?
If that more or less sums up your assessment, can you provide your rationale? Just curious, because that is significantly less than other numbers I've heard (30k - 75k).
Very true, that new improved treatments are innevitable. But for now, just getting telaprevir apporved and on the market has to be the most urgent priority. No doubt a significant part of the earnings from that will certainly be applied to either internal development or acquistion of potential new treatments in hep C or other areas of interest to allow Vertex to continue it's growth. In the meantime, it should be an exciting time for the company, it's investors, and most of all, the patients whose lives it stands to improve or save from serious disease.
-> Vertex's pipeline has the potential to sustain earnings growth for many years. <-
In my opinion, it is not too early for Vertex to start acquiring pipeline products now. It cannot depends only on its own scientists to come up with breakthrough drugs year after year. First and second generation drugs will be replaced by all oral drug regimen which skips the current SOC. Eventually, microRNA-122 based therapy will wipe out HCV from the Earth. From the speed of microRNA development this can happen within 10 years. The survival of Vertex depends critically on its pipeline investments beyond HCV drugs.