Aa
If you've got something to say,say it now
http://www.conservativeusa.org/mega-cong.htm (don't be fooled by the site name, it is basically a portal).
Every so often I fire off an e-mail to those who represent me . The link above will take you a site where you can find their e-mail addys. In addition to my reps and senators I try to pick some chairs of important committees like Charlie Rangel and Ted Kennedy, for example. They both chair committees that can increase or decrease the needed funding levels to achieve the best outcomes for those with HCV. Including the incarcerated and IVDU.
Every so often I fire off an e-mail to those who represent me . The link above will take you a site where you can find their e-mail addys. In addition to my reps and senators I try to pick some chairs of important committees like Charlie Rangel and Ted Kennedy, for example. They both chair committees that can increase or decrease the needed funding levels to achieve the best outcomes for those with HCV. Including the incarcerated and IVDU.
If I misunderstood some of your points in your post I apologize. Perhaps my jaded cynicism is spilling over.
From what I have heard and read about Vertex they would love to get this to market soon. The expense the CEO referred to is that of being prepared for a launch that may or may not occur. At the same time they are going forward with phase III trials since the FDA may or may not accept mid-trial data and approve the faster release date for the subset of patients who failed previous tx. I don't think Vertex is rolling in money like you do. They cashed out their HIV drugs for 160 million to help bring VX to market which isn't much. They have stated that they will need more money to fund phase III trials than they currently have.
"Boger (CEO) said preparing Vertex to scale up for a launch next year is expensive, but needs to be done because having telaprevir on the market as soon as possible will save lives."
We'll just have to agree to disagree about what motivates the market. The lack of timely data is what has hurt the stock the last 3 years and perhaps going forward it may hurt it even more. Getting earlier approval would be a godsend for their stock in my opinion. Then the incurred expense of a major drug launch won't be for nought, and the stock will soar on approval.
"The two-year wait for data from these pivotal telaprevir studies is a big reason for the decline in Vertex shares on Wednesday." --thestreet.com \
This link details further how the stock price has steadily declined for the last 3 years because of the same thing.
http://www.thestreet.com/story/10400013/1/vertex-vexed-by-fda-deal.html
I, too, am keeping my eye on all of the new drugs for basically the same reasons as you. I'm listed for tp and when the day draws nearer I may have to treat, and the shorter and less harsh the tx, the better. The SP drug is doing well as you noted and has a better safety profile to this point which would be very welcome if it holds.
I have lived for 35 years to a woman who sold securities for 20 years at The Rock.. No more stock talk for me. ;)
ML
From what I have heard and read about Vertex they would love to get this to market soon. The expense the CEO referred to is that of being prepared for a launch that may or may not occur. At the same time they are going forward with phase III trials since the FDA may or may not accept mid-trial data and approve the faster release date for the subset of patients who failed previous tx. I don't think Vertex is rolling in money like you do. They cashed out their HIV drugs for 160 million to help bring VX to market which isn't much. They have stated that they will need more money to fund phase III trials than they currently have.
"Boger (CEO) said preparing Vertex to scale up for a launch next year is expensive, but needs to be done because having telaprevir on the market as soon as possible will save lives."
We'll just have to agree to disagree about what motivates the market. The lack of timely data is what has hurt the stock the last 3 years and perhaps going forward it may hurt it even more. Getting earlier approval would be a godsend for their stock in my opinion. Then the incurred expense of a major drug launch won't be for nought, and the stock will soar on approval.
"The two-year wait for data from these pivotal telaprevir studies is a big reason for the decline in Vertex shares on Wednesday." --thestreet.com \
This link details further how the stock price has steadily declined for the last 3 years because of the same thing.
http://www.thestreet.com/story/10400013/1/vertex-vexed-by-fda-deal.html
I, too, am keeping my eye on all of the new drugs for basically the same reasons as you. I'm listed for tp and when the day draws nearer I may have to treat, and the shorter and less harsh the tx, the better. The SP drug is doing well as you noted and has a better safety profile to this point which would be very welcome if it holds.
I have lived for 35 years to a woman who sold securities for 20 years at The Rock.. No more stock talk for me. ;)
ML
There is no one more dismissive of conspiracy theories than-they are a pet hate of mine.
You have read me wrong!
I am not suggesting that Vertex are trying to play the market ( at least no more than any public quoted corporation).
There is some evidence that the drug could be crashed through to market see;
http://www.reuters.com/article/marketsNews/idUSN1948277620080619
I don't agree that the quicker they get the drug to market the quicker (or better) the shareholder return.It is expectation which the market responds to.Prformance is discounted long in advance.
There are are other compounds on it's tail (Boceprevir) and to provide sharholder return which is reflected at this stage in the share price rather than revenues and profits Vertex are keen to release fuirther data which consildates the drugs potential as an SOC ingredient.
I am myself waiting for this drug ( I am a two time non responder and one time relapser with advanced fibrosis/early cirrhosis) and have been tracking it since an early press release in 2000.If only I had bought stock then!
If others wish to lobby (I am in the U.K so not relevant to me) fine.I was merely lowering expectations that doing so would in this case affect the timeline.I know perfectly well that the weight of public opinion can alter legistlation.You will note the quote from the Vertex CEO that realease next year would be more expensive for the company which rather underlines my point and negates yours which appears to be 'The quicker the better for Verex'
You have read me wrong!
I am not suggesting that Vertex are trying to play the market ( at least no more than any public quoted corporation).
There is some evidence that the drug could be crashed through to market see;
http://www.reuters.com/article/marketsNews/idUSN1948277620080619
I don't agree that the quicker they get the drug to market the quicker (or better) the shareholder return.It is expectation which the market responds to.Prformance is discounted long in advance.
There are are other compounds on it's tail (Boceprevir) and to provide sharholder return which is reflected at this stage in the share price rather than revenues and profits Vertex are keen to release fuirther data which consildates the drugs potential as an SOC ingredient.
I am myself waiting for this drug ( I am a two time non responder and one time relapser with advanced fibrosis/early cirrhosis) and have been tracking it since an early press release in 2000.If only I had bought stock then!
If others wish to lobby (I am in the U.K so not relevant to me) fine.I was merely lowering expectations that doing so would in this case affect the timeline.I know perfectly well that the weight of public opinion can alter legistlation.You will note the quote from the Vertex CEO that realease next year would be more expensive for the company which rather underlines my point and negates yours which appears to be 'The quicker the better for Verex'
When a drug is granted fast track status as VX-950 was, the company may file new drug applications for each section of the trials. They don't need FDA's 'acceptance' as this is part of the FDA's own rules. And using this method gets the drug to market even faster so it's to the benefit of the company, the shareholders as well as the patient to do it this way. They do not hold back on the urgency, as the sooner they get to market the faster the stockholders can see a return, which will increase the stock's value, and as you pointed out that is their number one job. You are right about where Vertex's fiduciary duties lie. But they are not 'tweaking' the tx protocol per se. They are establishing new protocols for new trials in an attempt to show their product is a proven therapy for all classes of HCV patients:naive,null,non, and relapse. This is simply a way to corner the market. Vertex stock has been steady for over 3 years and recently gone down, so I don't see any evidence of them trying to 'play' the market. A company could go under manipulating the release of info. If you are the first on the block you don't have to play any games and risk the SEC bringing charges of holding back to barely change share prices (Vertex virtually unchanged share price since 12-06.). The big stock rise will happen after approval of each section and again more after it shows some real world success. The officers and shareholders all recognize this fact. When that happens the planet will be throwing money at them, so I have to disagree with your conspiracy theory. And it was a conspiracy theory when you think about how many people would have to be in collusion and would have to keep it a secret. NO ONE can keep a secret.
The makers of Infergen are a great example of being granted approval for a subset of patients. They specifically tested using prior relapsers and non-responsders and were approved for that purpose originally. Everyone knows that INF alpha under any brand name is just as effective.
My original post was not for any purpose other than to let your reps and senators know about how feel about any topic related to HCV. But if hopeful51 wants to unload about faster approval I certainly will point her in the right direction without assessing whether it will do no good. I remember when there was no such thing as fast track status and as I recall, it was the public's outcry that got the regulations changed. The first letter of complaint urging reform had to be written by just one person, no ?
Mr Liver
The makers of Infergen are a great example of being granted approval for a subset of patients. They specifically tested using prior relapsers and non-responsders and were approved for that purpose originally. Everyone knows that INF alpha under any brand name is just as effective.
My original post was not for any purpose other than to let your reps and senators know about how feel about any topic related to HCV. But if hopeful51 wants to unload about faster approval I certainly will point her in the right direction without assessing whether it will do no good. I remember when there was no such thing as fast track status and as I recall, it was the public's outcry that got the regulations changed. The first letter of complaint urging reform had to be written by just one person, no ?
Mr Liver
I believe that FDA would be willing to consider a New Drug Application for VX 950 on the strength of the Phase2a trials.
It is Vertex who have chosen not to file until completing a full Phase 3.
Vertex are not keen to rush the drug to market.
Their principal responsibility is to shareholders not to patients.
They are well funded and do not need the sales income at this point.
They want to keep tweaking the treatment protocol and releasing selected data to buoy up the share price.
I dont think petioniing will help.
This is big business not a mercy mission-expect approval for treament failure patients not sooner than late 2010.
It is Vertex who have chosen not to file until completing a full Phase 3.
Vertex are not keen to rush the drug to market.
Their principal responsibility is to shareholders not to patients.
They are well funded and do not need the sales income at this point.
They want to keep tweaking the treatment protocol and releasing selected data to buoy up the share price.
I dont think petioniing will help.
This is big business not a mercy mission-expect approval for treament failure patients not sooner than late 2010.
I could be wrong but I think vx-950 is already on what is called 'fast track status". Sen Kennedy is chairman of the committee that handles health care and all things related.
He might be a good place to voice your concerns with in addition to your Representative and Senators.
Mr Liver
He might be a good place to voice your concerns with in addition to your Representative and Senators.
Mr Liver
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.
