"With no viralogic breakthrough and no discontinuations due to 7977, the next step was to determine if a 12-week triple therapy regimen in Genotype 1 without 12-week peg as a follow-on would achieve the same high response rate. The ATOMIC study is currently evaluating a total of 12 weeks of therapy in patients with Genotype 1 and is also studying longer duration therapy in order to establish the safety database for PSI-7977 for up to 24 weeks of therapy.
The high response rates in Genotype 1 as well as the 94% to 100% response rates in patients with Genotype 2 or 3 led to the belief that only 12 weeks of total duration could be required across Genotype, but also the question of determining the role of interferon in these PSI-7977 regimen. Together with our advisors we designed ELECTRON to determine the impact of reducing the total number of injections of interferon that would be necessary to retain that same high SVR. Those data will be shared in detail later this week by Dr. Ed Gane. Emerging data from ELECTRON were shared with the health authorities and together with the response rates in this population supported the interferon regimen that we will be taking forward into registrational studies."
The sentencebelow lifted from the above:
"Together with our advisors we designed ELECTRON to determine the impact of reducing the total number of injections of interferon that would be necessary to retain that same high SVR. Those data will be shared in detail later this week by Dr. Ed Gane."
makes it sound like they may have encountered viral breakthrough with their all oral regiment and now they are tweeting with how much interferon should be added to the regiment? Maybe Dorkbuster can comment on this since he has kept up with VRUS's progress.
"Note that the third phase III that treats G1 will take till mid 2012."
Your above statement may imply that phase 3 will conclude in mid 2012. As you know it will START in mid 2012. A world of difference.
You are right about management. My praise goes to the scientists working out of the limelight.
Don't get too caught up in the manipulation theory. Value is eventually realised. What's happening lately is an adjustment to competitive threats.
Wrong, in hockey and other sports, it's being monitored and fair. Of course there are blown calls. Here since there is very little float, mostly owned by institutions, hedge funds can manipulate the price.
Yes I'm disgusted but I do know VRTX does have a great product, just mgmt does not care too much to the individual investors. Example- look at dilution when they need funds.
VRTX is making incredible advancements in personalized medicine (CF). Unfortunately they face intense competition in HCV from VRUS. If you are perplexed about what's going on today you are already behind the curve. As Gretzky once said "A good hockey player plays where the puck is. A great hockey player plays where the puck is going to be." The market is no different.
Bottom line who cares what we think, VRUS is up over $7 or 10% since the call and after our great third Q call DOWN $8 or 20%. It's wonderful to have a phase 2 product than an FDA approved product generating money!
From Third's comments
"Notice that all treatment arms of Genotype 2/3 contains Ribavirin. I know that the chance for SVR is greater for the patients infected with GT 2/3 virus than the chance for the patients with GT1 whether or not interferon is included in the cocktail. This means that the PSI-7977 monotherapy has failed to give meaningful results for GT 2/3. And although the trial design for Ph 3 of GT 1 has not beeen completed, it must contain Riba because it is harder to treat.
Don't worry about Abbott, BMS, and others. VRUS's all oral is the only challenge VRTX is facing now. The monotherapy against GT1 will fail."
Listening to the VRUS conference Q&A, it is apparent what their game plan is regarding the treatment of genotype 1 HCV. My guess is that their all-oral PSI-7977/ribavirin cure rate will be very inferior to Incivek/peg-interferon/ribavirin but they will say that it is a superior regimen because most patients cannot/will not tolerate interferon.
From the conference Q&A:
"...88% of veterans who have HCV infection have not been treated. And again, a majority of those are because they are ineligible for interferon therapy." -- M. Michelle Berrey
"With respect to the competitiveness clearly an interferon free regimen, any SVR is actually a significant improvement." -- PATRICK T. HIGGINS
This is the first time I have heard that most patients are "ineligible" for interferon therapy. I think it's B.S., especially with Incivek's shortened treatment durations for many patients.
"Emerging data from ELECTRON were shared with the health authorities and together with the response rates in this population supported the interferon (free) regimen that we will be taking forward into registrational studies."
Note the typo in the transcript I highlighted in parentheses.
ELECRTON was an interferon-sparing study designed to demonsrate how worthless interferon is when used with PSI-7977.
If i am a doctor, i would care alot about a study and report. But I want to make money so I care more about what Stupid Analyst would say that woud effect the stock price. As of now they want to hurt this company so VRTX will keep going down. may because they want pump up other company.