Aa
Is this true???
This was just posted on the Vertex message board. Hope it's wrong. Does anyone know about this?
Unfortunately, VRTX did not do a dose finding study in phase I with concern of QTc prolongation suggested from In-Vitro study, which has been a class side effect of small molecular drug. FDA has a guideline that all small molecular drugs have to have a special trial to exclude this class side effect. VRTX might have done such a study with a smaller dose that did not induce such class effect, but may not satisfy the government agency. Also, their phase I and II were using different formulation (phase I was a suspension, and phase II was a pill), therefore, these data were non-comparable. They messed up by themselves, and the people who in charged the clinical trials should all be fired.
Unfortunately, VRTX did not do a dose finding study in phase I with concern of QTc prolongation suggested from In-Vitro study, which has been a class side effect of small molecular drug. FDA has a guideline that all small molecular drugs have to have a special trial to exclude this class side effect. VRTX might have done such a study with a smaller dose that did not induce such class effect, but may not satisfy the government agency. Also, their phase I and II were using different formulation (phase I was a suspension, and phase II was a pill), therefore, these data were non-comparable. They messed up by themselves, and the people who in charged the clinical trials should all be fired.
Mremeet - Thanks. That is what I thought also, but I wanted it confirmed by the company, which they did yesterday. By the way, do you know what % do not rvr, but svr with SOC? With triple therapy?
Proactive - Certainly everyone should be balanced and look at all of the pros and cons when initially cosidering a treatment or an investment. But in conversation, I certainly don't expect a supporter of a point of view to have to always acknowledge all of the pros and cons every time they show their support. But, there are certainly many ways of approaching a discussion.
Cheers!
Proactive - Certainly everyone should be balanced and look at all of the pros and cons when initially cosidering a treatment or an investment. But in conversation, I certainly don't expect a supporter of a point of view to have to always acknowledge all of the pros and cons every time they show their support. But, there are certainly many ways of approaching a discussion.
Cheers!
3txquote: "Though, need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patientsKidney diet - dialysis patients stop all treatment at 24 weeks."
I think all they mean is that as long as you perform well and go UND within 2 or 3 weeks you'll be considered ok to stop at 24 weeks. If you take longer than that, then you'll be extended to a full 48 weeks. This helps to ensure everyone has a fair shot of snagging their SVR, instead of stopping at 24 weeks even if you had a sluggish response (which would forbode a failed tx if stopped too early). Plus this'll help make their SVR trial rates come out higher, which will help bolster everyone's perceptions of how well the drug works.
I think all they mean is that as long as you perform well and go UND within 2 or 3 weeks you'll be considered ok to stop at 24 weeks. If you take longer than that, then you'll be extended to a full 48 weeks. This helps to ensure everyone has a fair shot of snagging their SVR, instead of stopping at 24 weeks even if you had a sluggish response (which would forbode a failed tx if stopped too early). Plus this'll help make their SVR trial rates come out higher, which will help bolster everyone's perceptions of how well the drug works.
That's it, quote Truman? That's all you got for me for downside? I can certainly see the positive side, higher svr,shorter tx times, many even some corporate profits....But I sure as heck can see the downsides as well, lengthy fda process, additional trials, rash, anemia, higher drop out rates in phase 2 than phase 1.....Heck, the company doesn't have enough cash and equivlents to even bring the product to market....where do you think additional capital will come from?.....answer is out of the share price.....and that should be reflected from additonal funding..ie, more shares, more convertible divy paying bonds, or possibly giving away more future sales to JnJ....come on, give me balance!!...sorry, under 500 riba to go now....;^)
Harry Truman once asked famously - "Are there no one handed economists?" Truman being quite tired of economists suggesting one course of action, only to continue with 'on the other hand'.
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view. For me, pumpers and bashers cross a line when they use dishonest or distorted or highly selective arguments to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Though, need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view. For me, pumpers and bashers cross a line when they use dishonest or distorted or highly selective arguments to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Though, need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
Harry Truman once asked famously - "Are there no one handed economists?" Truman being quite tired of economists suggesting one course of action, only to continue with 'on the other hand'.
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view. For me, pumpers and bashers cross a line when they use dishonest or distorted or highly selective arguments to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Though, need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view. For me, pumpers and bashers cross a line when they use dishonest or distorted or highly selective arguments to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Though, need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
Harry Truman once asked famously - "Are there no one handed economists?" Truman being quite tired of economists suggesting one course of action, only to continue with 'on the other hand'.
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
Harry Truman once asked famously - "Are there no one handed economists?" Truman being quite tired of economists suggesting one course of action, only to continue with 'on the other hand'.
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
I have no problem with posters who are primarily pro or con, as long as they give solid facts to support their point of view.
I own some VRTX, and I am on the whole positive. I view it as a very long term investment, though it would have been nice to sell at 40 and I am experiencing mild pain here. But, I didn't buy the Vertex for a quick trade.
Technically, the stock seems to be hammering out a bottom at about 21. So, support could be there. By the way today's press release seems to be contradictory of the Wachovia comments of last week. Need to see at the conference today exactly what is meant by - "The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks."
I consider a pumper as one who has no objectivity, who refuses to, or is incapable of seeing both sides of a coin....One who continuously trys to convince others of the upside only...the Motely fools would fit this catagory as well in my opinion (course they seems to have moved to more furtile ground)....Just as bad are those who refuse to discuss the upside potential....bop, joan etc...their is no balance, thus no credibility....
where do you stand? What do you see as downside? Where does willows stand since our discussion @ $36/sh?
where do you stand? What do you see as downside? Where does willows stand since our discussion @ $36/sh?
I follow the yahoo board as well. The post you cited in the opening of this thread is by joano2148, who has been shown to be a serially liar. She recently posted the following - "THE FAST TRACK STATUS IS ONLY GRANTED TO THE DRUG THAT TREATS THE TERMINAL DISEASES, NOT HEPC." She has posted similar BS as well. The poster dukeshaw seems to have taken apart her recent claims.
It is quite common on yahoo boards for people who want a share price to fall, to post dishonestlly in an attempt to create FUD (Fear, uncertainty and dread) on the part of shareholders, as FUD leads to panic selling. These posters are bashers, the opposite of pumpers.
I'm not sure why proactive attacks - thirdmeinvestor, justrpaul and gladpick, they are generally pro-vertex, but they seem to post objective information. They have thier opinions as well, but I haven't seen any of them post dishonest or distorted information. So, I would not classify them as pumpers.
As far as forecast, I stick with my late 2009 approval.
It is quite common on yahoo boards for people who want a share price to fall, to post dishonestlly in an attempt to create FUD (Fear, uncertainty and dread) on the part of shareholders, as FUD leads to panic selling. These posters are bashers, the opposite of pumpers.
I'm not sure why proactive attacks - thirdmeinvestor, justrpaul and gladpick, they are generally pro-vertex, but they seem to post objective information. They have thier opinions as well, but I haven't seen any of them post dishonest or distorted information. So, I would not classify them as pumpers.
As far as forecast, I stick with my late 2009 approval.
Copy, looks like you won't have to wait for the webcast...here it is in a nutshell, without the dog and pony show fluff....Note the 48 week arm.....I'll stick with 2012 approval-if approved.
"Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update
Monday January 7, 8:01 am ET
- Formal European scientific advice obtained for telaprevir development program -
- Meeting scheduled with FDA for January 2008 on Phase 3 trial design and recent data -
- Next-generation HCV protease inhibitor and two investigational compounds for cystic fibrosis in clinical development -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced its key business objectives for 2008 and provided an overview of recent developments, including highlights from research and development programs, in conjunction with the 26th Annual JPMorgan Healthcare Conference in San Francisco. At the conference, Joshua Boger, Ph.D., President and Chief Executive Officer, and Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development, will today review Vertex’s HCV product development and commercialization strategy. A live webcast of this presentation will be available on Vertex’s website, www.vrtx.com, today at 2:00 p.m. PST (5:00 p.m. EST).
ADVERTISEMENT
“As we enter 2008, Vertex is focused on initiating a Phase 3 clinical program for telaprevir, our lead investigational hepatitis C protease inhibitor,” stated Dr. Boger. “Clinical data generated in 2007 has provided a platform for constructive dialogue with U.S. and E.U. regulatory authorities, and in early 2008 we look forward to completing these discussions and advancing telaprevir into pivotal clinical development.”
Dr. Boger continued, “As we advance toward the initiation of a Phase 3 development program for telaprevir, and with the expansion of our investigational HCV portfolio to include next-generation protease inhibitors, we believe we will be well-positioned to establish leadership in the HCV treatment landscape.”
Telaprevir Regulatory Update for Treatment-Naïve Genotype 1 Patients
In collaboration with Vertex, Tibotec is developing and commercializing telaprevir in Europe, South America, Australia, the Middle East and other countries. Tibotec has obtained formal scientific advice from European regulatory authorities on the telaprevir development program. Following receipt of this formal scientific advice, Vertex has submitted a Phase 3 protocol to the U.S. Food and Drug Administration (FDA) for review. The submitted Phase 3 trial design includes a 48-week control arm and both 8 and 12 weeks of telaprevir treatment as part of 24-week combination treatment regimens. The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks.
Vertex plans to review this Phase 3 clinical trial design, as well as recently submitted clinical data, at a scheduled meeting with the FDA in January 2008. Tibotec is also in the process of finalizing Phase 3 development plans in Europe. Vertex expects to provide an update on its discussions with the FDA no later than February 11, 2008, the planned date of its year-end financial results conference call.
Telaprevir Clinical Development Plans for Treatment-Failure Genotype 1 Patients
Vertex is conducting PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who have not achieved a sustained viral response (SVR) with a previous pegylated interferon-based treatment. Vertex plans to discuss with regulatory authorities in mid-2008 the next steps in the telaprevir development program for treatment-failure HCV patients after the first interim clinical data are available from the PROVE 3 clinical trial.
Tibotec Leading Two Clinical Trials of Telaprevir in Europe
Tibotec initiated in late 2007 a Phase 2 clinical study in Europe to evaluate 8-hourly and 12-hourly dosing of telaprevir in combination with pegylated interferon (Pegasys® or Pegintron®) and ribavirin. Patients are currently being dosed in this trial. Interim 12-week on-treatment data are expected to be available in the second half of 2008.
Tibotec is also conducting a Phase 2 viral kinetics study in Europe to evaluate telaprevir in patients infected with genotype 2/3 HCV. Patients are currently being screened in this trial, and interim on-treatment data are expected to be available in late 2008.
Additional Telaprevir Research Conducted in 2008
Also in 2008, Vertex intends to initiate clinical exploration of telaprevir in combination with other investigational HCV therapies."
"Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update
Monday January 7, 8:01 am ET
- Formal European scientific advice obtained for telaprevir development program -
- Meeting scheduled with FDA for January 2008 on Phase 3 trial design and recent data -
- Next-generation HCV protease inhibitor and two investigational compounds for cystic fibrosis in clinical development -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced its key business objectives for 2008 and provided an overview of recent developments, including highlights from research and development programs, in conjunction with the 26th Annual JPMorgan Healthcare Conference in San Francisco. At the conference, Joshua Boger, Ph.D., President and Chief Executive Officer, and Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development, will today review Vertex’s HCV product development and commercialization strategy. A live webcast of this presentation will be available on Vertex’s website, www.vrtx.com, today at 2:00 p.m. PST (5:00 p.m. EST).
ADVERTISEMENT
“As we enter 2008, Vertex is focused on initiating a Phase 3 clinical program for telaprevir, our lead investigational hepatitis C protease inhibitor,” stated Dr. Boger. “Clinical data generated in 2007 has provided a platform for constructive dialogue with U.S. and E.U. regulatory authorities, and in early 2008 we look forward to completing these discussions and advancing telaprevir into pivotal clinical development.”
Dr. Boger continued, “As we advance toward the initiation of a Phase 3 development program for telaprevir, and with the expansion of our investigational HCV portfolio to include next-generation protease inhibitors, we believe we will be well-positioned to establish leadership in the HCV treatment landscape.”
Telaprevir Regulatory Update for Treatment-Naïve Genotype 1 Patients
In collaboration with Vertex, Tibotec is developing and commercializing telaprevir in Europe, South America, Australia, the Middle East and other countries. Tibotec has obtained formal scientific advice from European regulatory authorities on the telaprevir development program. Following receipt of this formal scientific advice, Vertex has submitted a Phase 3 protocol to the U.S. Food and Drug Administration (FDA) for review. The submitted Phase 3 trial design includes a 48-week control arm and both 8 and 12 weeks of telaprevir treatment as part of 24-week combination treatment regimens. The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks.
Vertex plans to review this Phase 3 clinical trial design, as well as recently submitted clinical data, at a scheduled meeting with the FDA in January 2008. Tibotec is also in the process of finalizing Phase 3 development plans in Europe. Vertex expects to provide an update on its discussions with the FDA no later than February 11, 2008, the planned date of its year-end financial results conference call.
Telaprevir Clinical Development Plans for Treatment-Failure Genotype 1 Patients
Vertex is conducting PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who have not achieved a sustained viral response (SVR) with a previous pegylated interferon-based treatment. Vertex plans to discuss with regulatory authorities in mid-2008 the next steps in the telaprevir development program for treatment-failure HCV patients after the first interim clinical data are available from the PROVE 3 clinical trial.
Tibotec Leading Two Clinical Trials of Telaprevir in Europe
Tibotec initiated in late 2007 a Phase 2 clinical study in Europe to evaluate 8-hourly and 12-hourly dosing of telaprevir in combination with pegylated interferon (Pegasys® or Pegintron®) and ribavirin. Patients are currently being dosed in this trial. Interim 12-week on-treatment data are expected to be available in the second half of 2008.
Tibotec is also conducting a Phase 2 viral kinetics study in Europe to evaluate telaprevir in patients infected with genotype 2/3 HCV. Patients are currently being screened in this trial, and interim on-treatment data are expected to be available in late 2008.
Additional Telaprevir Research Conducted in 2008
Also in 2008, Vertex intends to initiate clinical exploration of telaprevir in combination with other investigational HCV therapies."
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will webcast its corporate presentation at the 26th Annual JPMorgan Healthcare Conference on Monday, January 7, 2008 at 2:00 p.m. PST (5:00 p.m. EST).
The presentation will be webcast live and may be accessed from the ‘Events & Presentations’ page of Vertex’s website at www.vrtx.com. A replay of the webcast will also be available on the Company’s website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast."
The presentation will be webcast live and may be accessed from the ‘Events & Presentations’ page of Vertex’s website at www.vrtx.com. A replay of the webcast will also be available on the Company’s website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast."
For those that want to follow this particular thread on the Vertex board, here's the link:
http://tinyurl.com/2oz8pm
You can start at "joan02148"'s third post today, 1/8, that starts with "Unfortunately, VRTX did not do a do."
http://tinyurl.com/2oz8pm
You can start at "joan02148"'s third post today, 1/8, that starts with "Unfortunately, VRTX did not do a do."
proactive.............what, you don't wanna go to martha stewart heaven??
JR, I'd be very suspicious of that info, it would basically mean the company hired dumb and dumber for their most promising profit maker to date. It'd be suicidal.
not that it couldn't happen....
but if you've ever dealt with wall street you'd know that Merril "Lynch" earned their name... hung more by the neck with press releases than the south did with hemp neckties.
JR, I'd be very suspicious of that info, it would basically mean the company hired dumb and dumber for their most promising profit maker to date. It'd be suicidal.
not that it couldn't happen....
but if you've ever dealt with wall street you'd know that Merril "Lynch" earned their name... hung more by the neck with press releases than the south did with hemp neckties.
The Vertex message board?? You mean on some stock trader site? If so I'd be wary of anything written there. I think a Vertex conference is scheduled tomorrow, hopefully we'll get the skinny on what's up with phase 3 and where the FDA stands on Telaprevir's progress right now.
CAMBRIDGE, Mass., Jan 03, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its corporate presentation at the 26th Annual JPMorgan Healthcare Conference on Monday, January 7, 2008 at 2:00 p.m. PST (5:00 p.m. EST).
this webcast might answer your question. As far as I know they still maintain a late 2008 fda approval. They can't lie to these people so it should be interesting.
Ron
this webcast might answer your question. As far as I know they still maintain a late 2008 fda approval. They can't lie to these people so it should be interesting.
Ron
Ladywhy - Do you mean explain what I wrote or what Proactive wrote? What I wrote was a post about how Vertex messed up their Prove 1 and Prove 2 trials, so that telaprevir won't be approved for a very long time.
Proctive- you got that right! Gladpick started the thread that this came from. No sign of the others 2 yet. S.
Proctive- you got that right! Gladpick started the thread that this came from. No sign of the others 2 yet. S.
Who knows if there is any truth in the post you quoted...But one thing is for sure, that should certainly set off the three pumping amigos, gladpick,justrpaul and thirdmeinvestor on the yahoo board...Heck they'll be out quoting 2 year old info before you know it...buy,buy,buy...lot's of institutional accumulation, darn shorts......yada,yada,yada.....;^)
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
