Comments on: The FDA should approve Provenge now! http://provenge.wordpress.com/2007/05/21/hello-world/ Tue, 07 Oct 2008 23:24:52 +0000 http://wordpress.com/ hourly 1 By: gilbert k taylor http://provenge.wordpress.com/2007/05/21/hello-world/#comment-21 gilbert k taylor Fri, 06 Jul 2007 11:01:01 +0000 #comment-21 In your rush to have a drug approved, remember vioxx and phen-phen. I'm not sure I actually have the correct web-site of the person in Alabama, but if it is, he has a conflict of interest for the drug to be approved since he's an investor in the biotech company that created the drug. In your rush to have a drug approved, remember vioxx and phen-phen. I’m not sure I actually have the correct web-site of the person in Alabama, but if it is, he has a conflict of interest for the drug to be approved since he’s an investor in the biotech company that created the drug.

]]> By: Cliffhucker http://provenge.wordpress.com/2007/05/21/hello-world/#comment-20 Cliffhucker Wed, 06 Jun 2007 22:22:18 +0000 #comment-20 You can find the Video of the 3/29 AC meeting at my blog in the Video section. Just click my username cliffhucker above. You can find the Video of the 3/29 AC meeting at my blog in the Video section.
Just click my username cliffhucker above.

]]> By: don http://provenge.wordpress.com/2007/05/21/hello-world/#comment-19 don Wed, 06 Jun 2007 08:49:08 +0000 #comment-19 It is one thing to read the transcript but to watch it is beyond words.. you must watch it. go to IV and ask for link..How in Gods name can the FDA delay this drug...after watching the vidio.....May God have no mercy for Dr V E , DR.Hussein. Dr Sheir, as they have no mercy for the PC patients......that are dieing every day....You must watch and ask your self what is the FDA doing.... It is one thing to read the transcript but to watch it is beyond words.. you must watch it. go to IV and ask for link..How in Gods name can the FDA delay this drug…after watching the vidio…..May God have no mercy for Dr V E , DR.Hussein. Dr Sheir, as they have no mercy for the PC patients……that are dieing every day….You must watch and ask your self what is the FDA doing….

]]> By: CrossProfit http://provenge.wordpress.com/2007/05/21/hello-world/#comment-17 CrossProfit Sun, 03 Jun 2007 23:26:07 +0000 #comment-17 Why doesn't DNDN get the drug approved outside the US. This has been done before. Then patients would have access and the FDA would have to capitulate. Just a thought. Why doesn’t DNDN get the drug approved outside the US. This has been done before. Then patients would have access and the FDA would have to capitulate.

Just a thought.

]]> By: Richard Cory http://provenge.wordpress.com/2007/05/21/hello-world/#comment-15 Richard Cory Tue, 29 May 2007 21:55:53 +0000 #comment-15 The Provenge CR letter makes me worry that the "Chemo Cartel" has bought the FDA and that terminal patients have been relegated to afterthoughts. The Provenge CR letter makes me worry that the “Chemo Cartel” has bought the FDA and that terminal patients have been relegated to afterthoughts.

]]> By: Stop_Moaning http://provenge.wordpress.com/2007/05/21/hello-world/#comment-14 Stop_Moaning Tue, 29 May 2007 07:26:46 +0000 #comment-14 You obviously have little experience with biotechnology. The FDA has hordes of these companies that bring that products up for BLA/NDA approval. The FDA does not and should not lower its standards for ANY product. Provenge is not proven to extend lives, it just appears that the data from two small trials demonstrates this. It must be proven. Period. Again as I wrote before, I think you and many others on this blog are rookie biotech investors that took your first FDA slam loss. Next time do your homework and learn to read the market. The "answer" was in the volume when the price surged to $25 and then in 10 minutes dropped to $21. Someone knew what was coming. If they were to receive approval the FDA would have been working with Dendreon on labeling issues for the new drug. Obviously this did not happen and alarm bells went off. Also the CEO selling a load at $13 was a serious red flag that all was not well in DNDN land. Lick your wounds, learn from your mistakes and do better next time. Prostrate cancer patients will not suffer if this turns out to be snakeoil. Also, Provenge will be available to those who ask for it. Have you ever heard of compassionate use? This is of course up to DNDN, if they refuse compassionate use, then you know what they are all about, money and nothing more. Only safe and effective drugs should go to market. Period. Thanks FDA for not bending to pressure from losing Biotech investors. Kudos to Dick Pazdur !!! You obviously have little experience with biotechnology. The FDA has hordes of these companies that bring that products up for BLA/NDA approval. The FDA does not and should not lower its standards for ANY product. Provenge is not proven to extend lives, it just appears that the data from two small trials demonstrates this. It must be proven. Period. Again as I wrote before, I think you and many others on this blog are rookie biotech investors that took your first FDA slam loss. Next time do your homework and learn to read the market. The “answer” was in the volume when the price surged to $25 and then in 10 minutes dropped to $21. Someone knew what was coming. If they were to receive approval the FDA would have been working with Dendreon on labeling issues for the new drug. Obviously this did not happen and alarm bells went off. Also the CEO selling a load at $13 was a serious red flag that all was not well in DNDN land.

Lick your wounds, learn from your mistakes and do better next time.

Prostrate cancer patients will not suffer if this turns out to be snakeoil. Also, Provenge will be available to those who ask for it. Have you ever heard of compassionate use? This is of course up to DNDN, if they refuse compassionate use, then you know what they are all about, money and nothing more.

Only safe and effective drugs should go to market. Period.

Thanks FDA for not bending to pressure from losing Biotech investors. Kudos to Dick Pazdur !!!

]]> By: Cliffhucker http://provenge.wordpress.com/2007/05/21/hello-world/#comment-12 Cliffhucker Mon, 28 May 2007 23:35:54 +0000 #comment-12 Stop_Moaning Says: May 26th, 2007 at 2:27 pm "Why should sick people have to folk out $100,000 a treatment for something that is not sure to be really effective?" They do not "have to" they have a choice. If you were dying what other choice do you have? To die and take your money (insurance $) with you? Stop_Moaning Says: "Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway." Not true. There are certain criteria to enter into the trials. They are limited to a select group. Stop_Moaning Says: "Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge." Great, but right now there are no other choices. A dying person cannot "wait" for other alternatives. And once these alternatives to Provenge come out then there will be choices and if Provenge is deemed inferior then it can be taken off the market. I agree that the FDA cannot let just any drug on the market. If it is a "non-lifesaving" drug like a sleep aid or sexual aid etc then it by all means better be deemed not only 99% safe but also very effective. And the FDA should take its time in making the decision on such types of drugs because life or death does not become the outcome of the decision. Stop_Moaning Says: "Don’t forget Provenge did not hit its primary targets in either phase III trial." Irrelevant, Provenge had better results than meeting those endpoints; provenge prove to extend life. This trumps all in my opinion (and those of the dying I am sure) If you walk up to a swimming pool and see a man drowning, you have a choice: 1)throw him your man made life ring that you have with you or 2)wait for a Coast Gaurd approved Life ring that is on its way. Which would you do? We know what the FDA would do. Stop_Moaning Says:
May 26th, 2007 at 2:27 pm
“Why should sick people have to folk out $100,000 a treatment for something that is not sure to be really effective?”

They do not “have to” they have a choice. If you were dying what other choice do you have? To die and take your money (insurance $) with you?

Stop_Moaning Says:
“Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway.”

Not true. There are certain criteria to enter into the trials. They are limited to a select group.

Stop_Moaning Says:
“Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge.”

Great, but right now there are no other choices.
A dying person cannot “wait” for other alternatives. And once these alternatives to Provenge come out then there will be choices and if Provenge is deemed inferior then it can be taken off the market.

I agree that the FDA cannot let just any drug on the market. If it is a “non-lifesaving” drug like a sleep aid or sexual aid etc then it by all means better be deemed not only 99% safe but also very effective. And the FDA should take its time in making the decision on such types of drugs because life or death does not become the outcome of the decision.

Stop_Moaning Says:
“Don’t forget Provenge did not hit its primary targets in either phase III trial.”

Irrelevant, Provenge had better results than meeting those endpoints; provenge prove to extend life. This trumps all in my opinion (and those of the dying I am sure)

If you walk up to a swimming pool and see a man drowning, you have a choice:

1)throw him your man made life ring that you have with you

or

2)wait for a Coast Gaurd approved Life ring that is on its way.

Which would you do? We know what the FDA would do.

]]> By: don http://provenge.wordpress.com/2007/05/21/hello-world/#comment-11 don Mon, 28 May 2007 06:26:29 +0000 #comment-11 If you walk up to a swimming pool and see a man drowning, you have a choice to throw him a Coast Gaurd approved life ring that floats and that has been shown to save people lives,what do you do ,a normal person would throw the life ring to save a life and, if you didn't in CA. you would be held liable for that mans death if you failed do do so... Here you have The FDA with a life saving drug and dieing PC Patients and DR VON E is refusing to let them have the drug ,AFTER HIS ON PANNEL SAYS IT IS SAFE AND WORKS he prefers to let them die, HE SHOULD BE HELD TO ACCOUNT FOR THESE MURDERS....WHO IS PROTECTING THESE PC PATIENTS FROM THE FDA AND DR VON DEATH WHEN THE RUBBER HITS THE ROAD THIS IS WHAT IS ALL ABOUT DR VON MONEY POLTICS AND BP KILLING THESE PATIENTS If you walk up to a swimming pool and see a man drowning, you have a choice to throw him a Coast Gaurd approved life ring that floats and that has been shown to save people lives,what do you do ,a normal person would throw the life ring to save a life and, if you didn’t in CA. you would be held liable for that mans death if you failed do do so… Here you have The FDA with a life saving drug and dieing PC Patients and DR VON E is refusing to let them have the drug ,AFTER HIS ON PANNEL SAYS IT IS SAFE AND WORKS he prefers to let them die, HE SHOULD BE HELD TO ACCOUNT FOR THESE MURDERS….WHO IS PROTECTING THESE PC PATIENTS FROM THE FDA AND DR VON DEATH

WHEN THE RUBBER HITS THE ROAD THIS IS WHAT IS ALL ABOUT DR VON MONEY POLTICS AND BP KILLING THESE PATIENTS

]]> By: Stop_Moaning http://provenge.wordpress.com/2007/05/21/hello-world/#comment-10 Stop_Moaning Sun, 27 May 2007 16:41:47 +0000 #comment-10 Yeah, yeah yeah. The FDA is Satan...etc. etc. You are the same type of folks who moan when the FDA lets an unsafe drug hit the market or a bottle of snakeoil that does nothing, then you scream "Where are the safeguards??? Where was the testing ????" "How could this happen???!" You can't have it both ways. Don't forget Provenge did not hit its primary targets in either phase III trial. The trials were small. They did not meet the normal standards of effectiveness checking. Why should Provenge get a "free pass" and a drug like Genasense be held to a higher standard? Why not just let drug makers sell anything to anyone because it "might" help (for $100,000+ a pop). Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway. Access is not a problem. I suspect you are mostly sour investors who lost your shirt in this. You should have taken profit in the 20's and headed for the exits until final word came from the FDA. Your greed got you a nasty loss. Welcome to biotech where fortunes are made and lost. The FDA might the RIGHT call here. Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge. Wouldn't you rather have a proven effective drug that you pay $100,000 for, than one where your not really sure? If I was shelling out $100,000, I would like to know that the product works. Would you buy a car that way??? Yeah, yeah yeah. The FDA is Satan…etc. etc. You are the same type of folks who moan when the FDA lets an unsafe drug hit the market or a bottle of snakeoil that does nothing, then you scream “Where are the safeguards??? Where was the testing ????” “How could this happen???!” You can’t have it both ways. Don’t forget Provenge did not hit its primary targets in either phase III trial. The trials were small. They did not meet the normal standards of effectiveness checking. Why should Provenge get a “free pass” and a drug like Genasense be held to a higher standard? Why not just let drug makers sell anything to anyone because it “might” help (for $100,000+ a pop). Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway. Access is not a problem. I suspect you are mostly sour investors who lost your shirt in this. You should have taken profit in the 20’s and headed for the exits until final word came from the FDA. Your greed got you a nasty loss. Welcome to biotech where fortunes are made and lost.

The FDA might the RIGHT call here. Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge. Wouldn’t you rather have a proven effective drug that you pay $100,000 for, than one where your not really sure? If I was shelling out $100,000, I would like to know that the product works. Would you buy a car that way???

]]> By: Elroy Smith http://provenge.wordpress.com/2007/05/21/hello-world/#comment-9 Elroy Smith Sun, 27 May 2007 16:09:17 +0000 #comment-9 Isn't our country about free enterprise. If the FDA finds its role in profit protection, then what do small companies or individual researchers have as incentive to provide exceptional cures. Perhaps they should just sell their research over to the large drug companies who control the current promise of new drugs. After all, the large established drug companies have already lobbied and swayed interest for themselves. Perhaps leaving the country will soon be the best option for the best treatment of PC. If put in the FDA's "prove you can handle any risk" position, shouldn't a US company should sell out to foriegn owners. Isn’t our country about free enterprise. If the FDA finds its role in profit protection, then what do small companies or individual researchers have as incentive to provide exceptional cures. Perhaps they should just sell their research over to the large drug companies who control the current promise of new drugs. After all, the large established drug companies have already lobbied and swayed interest for themselves.

Perhaps leaving the country will soon be the best option for the best treatment of PC. If put in the FDA’s “prove you can handle any risk” position, shouldn’t a US company should sell out to foriegn owners.

]]>