Buy The Obesity Drug Basket: ARNA, OREX, VVUS [View instapost]
"there was good patient compliance with only a 7% dropout rate due to adverse events."
If you talk about good patient compliance, you need to look at overall completion rate:
Arena: BLOSSOM - The Week 52 completion rate was higher for patients on lorcaserin 10 mg twice daily (57.2%) and 10 mg once daily (59.0%) compared to patients on placebo (52.0%).
Vivus: Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo, low-dose Qnexa and full-dose Qnexa, respectively; and Completion rates for CONQUER were 57%, 69%, 64% for patients taking placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.
Thus there is no advantage in this regard for Arena at all.
If you talk about safety, then you can use dropout due to AE where Arena has a little advantage. Vivus's efficacy advantage is very dramatic.
I guess you haven't read too many of his pieces to say something like this. He had written many positive ones on many biotech companies - and more often than not he was right when he wrote positive ones. I guess the negative ones always get more attention than those positive ones.
On Jul 29 09:45 AM VFC's Stock House wrote:
> Adam never rights positive pieces on a company > so it raised my suspicions when I saw him go positive on BDSI.
HEB: Pressure Mounting on FDA to Approve Ampligen for Chronic Fatigue [View article]
"It is my understanding that Ampligen can make the flu vaccine approximately 100 times more effective. If this is so, flu vaccine providers could use much less "flu material" to make up the vaccine (say 1/5 or even 1/10 as much). This would make the vaccine material the US received early go a much longer way. This might help avert a major pandemic. From the HEB studies for Ampligen for CFS, Ampligen is safe. From the Japanese studies, Ampligen is safe; and it is effective as a flu vaccine adjuvant. There does not appear to be a good reason not to use it."
Your understanding? It is wrong. Where did you get "from Japanese studies, Ampligen is safe"? Japanese studies were done in vitro, never tested on human. How do you know it is safe?
Your article is mostly based on conjecture. If FDA makes decision based on this type of standard, everyone in this country should be worried.
Is Medarex's Prostate Cancer Drug a Success? Too Early to Tell [View article]
I agree with user 435757, you should do more DD before writing this piece.
"WebMD quotes Derek Raghavan at the Cleveland Clinic as saying that androgen ablation can sometimes have dramatic results in patients with locally advanced prostate cancer, so it's impossible to say if ipilimumab is helping or not."
I agree with the caution whether the effect was due to Ipi or not. However, to dismiss it completely is also not credible. Did you ask anyone whether they had seen patients who have inoperable prostate cancer become operable after androgen ablation only?
Hemispherx Biopharma: Hot and Likely to Get Hotter [View article]
"The FDA has notified HEB that they need more time. If the FDA were certain of a rejection, they would not need any extra time. They could be running behind, but the FDA has taken a good look at the NDA by now."
I read so many comments like this. It just showed these people do not know FDA process that well. Do you need a few examples that FDA asked for more time, then came back with complete response letter (CRL)? CRL could simply ask for clarification, could also ask for new clinical trial.
On Jun 03 07:46 AM David White wrote:
> I have only said that I believe the chances for approval are significantly > better than 50%. I have not promised anyone HEB will definitely gain > approval for ampligen. > > Some points in favor of approval are: > 1. The reputation of HEB is clearly good (if not great). The FDA > has notified HEB that they need more time. If the FDA were certain > of a rejection, they would not need any extra time. They could be > running behind, but the FDA has taken a good look at the NDA by now. > There is at the very least something worth seriously considering > there. > 2. William Reeves and the Health and Human Services Department clearly > do not mind being thought to admire the ampligen invention. This > may not translate into approval. However, it does at the very least > translate into sincere respect. The fact that the other author called > the meeting an "ampligen love-in" gives you a clear idea of the tenor > of the meeting vis-a-vis ampligen. > 3. The recognition of HEB by the Italian government just before an > FDA decision is due can only help the odds of approval. Someone else > singing your praises before you ask for a promotion usually does. > The actual amount spent by the Italian government is not highly relevant. > They will have been at least reasonably careful about endorsing any > company. > > I know this analysis is not highly scientific. It is not really meant > to be. My gut feeling is telling me that a career researcher like > William Reeves would not emcee a "love-in" for a drug he thought > should be rejected. That "love-in" occurred on May 28, so he likely > knows most if not all of the data that the FDA is currently considering. > Of course, William Reeves thoughts may not be the same as those of > the FDA panel. Still this effective testimonial is very encouraging, > if you are hoping for approval. The fact that it was an HHS event > is also encouraging.
Book Review: Great Depression Ahead [View article]
On the other hand, the prediction that Obama is going to wreck the economy is not going to pan out either.
Raise tax on top earner to 90s level is not going to wreck the economy. If it were to raise to much higher level, then I would agree.
The key point is whether it is stock market, politics, people tend to predict the two extremes - that's where you get attention, the reality comes to somewhere in between.
On May 09 06:32 PM CuriousMonkey5 wrote:
> You seriously think Obama and the dems are going to fix everything > with their policies? How? With their shameful pork "stimulus" bill? > By raising taxes? With inefficient massive spending programs in areas > like energy and health care? Just because many voters are naive doesn't > mean these are good things to do. More likely they are exactly the > wrong things to do, especially now. Remember, the dems are not solving > for "doing the right thing," that is just the pitch to voters. They > are solving for controlling everything. >
Book Review: Great Depression Ahead [View article]
Agree. These types of opportunists predict extreme boom during booming years, and extreme bust during down years to get attention. They don't have consistent predictation record. The actual result falls somethere in between.
Instead you should read people like Jeremy Gratham, Warrent Buffet who have been consistently right.
There is no question US is in tough situation. The consumption is not going to be what it used to be in the past 10 years. The effect is going to be short term rather than permanent because in the long term it is good people are saving more money than spending. The economy is resilient enough to adjust to the new equilibrium.
On May 08 09:07 AM Davmors wrote:
> Harry Dent has no credibility. Let's remember that this is the guy > who predicted Dow 35,000 not too many years ago.
20 Stocks Which May Be Threatening Your Portfolio [View article]
The problem with the criteria is it uses the same criteria for different industry. It's laughable to use "economic margin" to evaluate for example developing biotech companies. They are valued by their pipelines and probabilities to bring the pipelines to market, not by economic margin.
An Alzheimer's Expert Discusses the Next Generation of Drugs [View article]
The problem with your argument is you only see one side of the story, not the other. You also didn't fully understand the whole process getting drug on the market the article is talking about.
1. Most research is done at universities. Really? Look at pharma/biotech R&D budget, you'll know who spent more. 2. It costs a fraction to produce avastin. Well it depends on how you count cost. Let's leave R&D budget out of the cost, do you know how much it costs to run phase I, II, III clinical trial to get the drug approved? The article gave example how many patients (thousands and thousands), and how long (several years) are needed to run ph III trial alone to get Alzheimer drug approved. These costs are actually higher than R&D. After running all these trials, the chance of success is very small. There are much more failures than success. Failure is part of cost. 3. Donate the discovery to the public. Well, if the public is willing to fund both R&D and clinical trials. There is no appetitie to fund both by the public.
On May 04 12:07 PM carey_jim wrote:
> Most research on Alzheimer's disease is done in universities and > not by the pharmaceutical industry. > > Drugs are overpriced because of advertisement costs and very high > profits for the drug industry, including kickbacks to the doctors > who prescribe these drugs. > > For example, the cancer drug Avastin costs $100,000 per year and > prolongs life by about 2 months. It costs a fraction of that to produce. > It is hyped by a huge advertisement campaign and then sold to desperate, > dying cancer patients who are grasping at straws. > > The movement in computer science that comes under the generic heading > Liinux is basically an attempt to keep prices for computer software > much lower than they are now for Microsoft and Apple software products. > > > It is based on the reasonable theory that the computer scientists > who invented the programs used by Microsoft, Apple and other large > companies, should make a very good living for their discoveries but, > as in the past, they should donate their scientific discoveries to > the public domain. (Think of the Theory of Relativity or the Salk > vaccine.) > > Drugs should also be considered scientific discoveries to be donated > to the public domain. That is NOT socialism either, by the way, any > more than it is socialism to believe that the mathematics used in > Relativity Theory should be owned by the public and should be available > to all scientists for free. > > I wonder when they will announce that we are going to have to pay > some large corporation royalties every time we use algebra? It would > do wonders for education ;)
Wells Fargo's Record Quarter - Really? [View article]
Obviously you even don't know how TARP works. Government didn't give WFC $25 billion interest free. Get the fact first before pouting nonsense.
On Apr 09 03:37 PM eddie shore wrote:
> so we gift WFC 25B interest free and they come up with a 3B profit. > now everyone is dancing in the street? just wait till AIG eeks out > a profit. i cant believe people are buying this crap. time to go > short
Maybe those who understand economics you described have their own agenda.
I understand economics. I think this is only reasonable plan (try) we have at the moment, better than the far right who want the banking system fail while ignore the much higher cost to the country and world, and the far left who want to nationalize the banking system while ignore the fact the government is no better at running business than private companies.
On Mar 22 12:08 PM Steve in Greensboro wrote:
> Nobody who understands economics thinks this mess will work.
Will Someone Remove Geithner from the Poker Table, Please? [View article]
Agree.
On Mar 22 11:55 AM punditobserver wrote:
> This article and following comments come off as the rantings of losers > and fools who dont know what they are talking about. > > Someone has to say it.
How Will the Geithner Plan for Banks Ever Get Approved? [View article]
You should know the detail of the plan first before you write the article. The plan doesn't need congress approval. It's based on already approved TARP money.
As of
"We're way past the point at which lawmakers trust Treasury to know what it's doing: they've done that in the recent past, with disastrous results, and they're not going to do it again. ",
who the hell trust congress any way? Congress should hike tax on their salary as much as AIG bonus because they approved the budget throughout the years ended up tax payer more than $10 trillion debt! They suddenly act like they really care about tax payer money.
Why It's Actually Different This Time [View article]
Many people keep making comments about Japan without fully understanding the extent of Japan's problem. To say we are doing the same thing as Japan did completely missed the point. Japan didn't do anything for years at first. I lived there before. Here are what I remember currently. The number might not be 100% accurate, but not far off either.
1. Japan had trade surplus, true, but they did have quite large government debt, as percentage of GDP, comparable to US if not more.
2. Japan's asset bubble was much larger in size percentage wise. Our housing market down 20-30%, theirs down 80-100% then more. Thus there was a huge difference in magnitude.
3. Japanese consumers wouldn't spend. They save 30-40%. As pessimestic as most people here are today, our decline of consumption is so small percentage wise relative to Japan. US consumers will never be like Japanese consumers. It's culture difference.
4. 90s was global boom, true. However, it was uncertain era for Japan due to the rise of China. China replaced many Japanese exports, which had forced Japan to change their economy significantly. Japan used to have life time job gurantee, but no more. The rise of China was negative to Japan in 90s.
On Mar 13 01:25 AM SB-tiger wrote:
> > Japan: in the 90s Japan tried every possible stimulus program – abut > one each year for a decade, almost paved the entire country side. > Nothing worked, it simply produced deflation. Japan had a lot of > things going for it – trade surplus, huge domestic savings, 90s was > the era of global boom – end of cold war, China, etc. We criticized > and admonished and advised Japan against it all. > > Now we are going to do everything they did – zombie banks, stimulus, > and the rest of it. We don’t have the money (unlike Japan) and this > is the first global recession since the great depression. >
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Latest | Highest ratedBuy The Obesity Drug Basket: ARNA, OREX, VVUS [View instapost]
If you talk about good patient compliance, you need to look at overall completion rate:
Arena: BLOSSOM - The Week 52 completion rate was higher for patients on lorcaserin 10 mg twice daily (57.2%) and 10 mg once daily (59.0%) compared to patients on placebo (52.0%).
Vivus: Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo, low-dose Qnexa and full-dose Qnexa, respectively; and Completion rates for CONQUER were 57%, 69%, 64% for patients taking placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.
Thus there is no advantage in this regard for Arena at all.
If you talk about safety, then you can use dropout due to AE where Arena has a little advantage. Vivus's efficacy advantage is very dramatic.
What Katrina Was to FEMA, Swine Flu Deaths Are to FDA - Buy BioCryst [View instapost]
Biotech Volatility: Antigenics, BioDelivery Sciences [View article]
On Jul 29 09:45 AM VFC's Stock House wrote:
> Adam never rights positive pieces on a company
> so it raised my suspicions when I saw him go positive on BDSI.
HEB: Pressure Mounting on FDA to Approve Ampligen for Chronic Fatigue [View article]
Your understanding? It is wrong. Where did you get "from Japanese studies, Ampligen is safe"? Japanese studies were done in vitro, never tested on human. How do you know it is safe?
Your article is mostly based on conjecture. If FDA makes decision based on this type of standard, everyone in this country should be worried.
Is Medarex's Prostate Cancer Drug a Success? Too Early to Tell [View article]
"WebMD quotes Derek Raghavan at the Cleveland Clinic as saying that androgen ablation can sometimes have dramatic results in patients with locally advanced prostate cancer, so it's impossible to say if ipilimumab is helping or not."
I agree with the caution whether the effect was due to Ipi or not. However, to dismiss it completely is also not credible. Did you ask anyone whether they had seen patients who have inoperable prostate cancer become operable after androgen ablation only?
Hemispherx Biopharma: Hot and Likely to Get Hotter [View article]
I read so many comments like this. It just showed these people do not know FDA process that well. Do you need a few examples that FDA asked for more time, then came back with complete response letter (CRL)? CRL could simply ask for clarification, could also ask for new clinical trial.
On Jun 03 07:46 AM David White wrote:
> I have only said that I believe the chances for approval are significantly
> better than 50%. I have not promised anyone HEB will definitely gain
> approval for ampligen.
>
> Some points in favor of approval are:
> 1. The reputation of HEB is clearly good (if not great). The FDA
> has notified HEB that they need more time. If the FDA were certain
> of a rejection, they would not need any extra time. They could be
> running behind, but the FDA has taken a good look at the NDA by now.
> There is at the very least something worth seriously considering
> there.
> 2. William Reeves and the Health and Human Services Department clearly
> do not mind being thought to admire the ampligen invention. This
> may not translate into approval. However, it does at the very least
> translate into sincere respect. The fact that the other author called
> the meeting an "ampligen love-in" gives you a clear idea of the tenor
> of the meeting vis-a-vis ampligen.
> 3. The recognition of HEB by the Italian government just before an
> FDA decision is due can only help the odds of approval. Someone else
> singing your praises before you ask for a promotion usually does.
> The actual amount spent by the Italian government is not highly relevant.
> They will have been at least reasonably careful about endorsing any
> company.
>
> I know this analysis is not highly scientific. It is not really meant
> to be. My gut feeling is telling me that a career researcher like
> William Reeves would not emcee a "love-in" for a drug he thought
> should be rejected. That "love-in" occurred on May 28, so he likely
> knows most if not all of the data that the FDA is currently considering.
> Of course, William Reeves thoughts may not be the same as those of
> the FDA panel. Still this effective testimonial is very encouraging,
> if you are hoping for approval. The fact that it was an HHS event
> is also encouraging.
Book Review: Great Depression Ahead [View article]
Raise tax on top earner to 90s level is not going to wreck the economy. If it were to raise to much higher level, then I would agree.
The key point is whether it is stock market, politics, people tend to predict the two extremes - that's where you get attention, the reality comes to somewhere in between.
On May 09 06:32 PM CuriousMonkey5 wrote:
> You seriously think Obama and the dems are going to fix everything
> with their policies? How? With their shameful pork "stimulus" bill?
> By raising taxes? With inefficient massive spending programs in areas
> like energy and health care? Just because many voters are naive doesn't
> mean these are good things to do. More likely they are exactly the
> wrong things to do, especially now. Remember, the dems are not solving
> for "doing the right thing," that is just the pitch to voters. They
> are solving for controlling everything.
>
Book Review: Great Depression Ahead [View article]
Instead you should read people like Jeremy Gratham, Warrent Buffet who have been consistently right.
There is no question US is in tough situation. The consumption is not going to be what it used to be in the past 10 years. The effect is going to be short term rather than permanent because in the long term it is good people are saving more money than spending. The economy is resilient enough to adjust to the new equilibrium.
On May 08 09:07 AM Davmors wrote:
> Harry Dent has no credibility. Let's remember that this is the guy
> who predicted Dow 35,000 not too many years ago.
20 Stocks Which May Be Threatening Your Portfolio [View article]
An Alzheimer's Expert Discusses the Next Generation of Drugs [View article]
1. Most research is done at universities. Really? Look at pharma/biotech R&D budget, you'll know who spent more.
2. It costs a fraction to produce avastin. Well it depends on how you count cost. Let's leave R&D budget out of the cost, do you know how much it costs to run phase I, II, III clinical trial to get the drug approved? The article gave example how many patients (thousands and thousands), and how long (several years) are needed to run ph III trial alone to get Alzheimer drug approved. These costs are actually higher than R&D. After running all these trials, the chance of success is very small. There are much more failures than success. Failure is part of cost.
3. Donate the discovery to the public. Well, if the public is willing to fund both R&D and clinical trials. There is no appetitie to fund both by the public.
On May 04 12:07 PM carey_jim wrote:
> Most research on Alzheimer's disease is done in universities and
> not by the pharmaceutical industry.
>
> Drugs are overpriced because of advertisement costs and very high
> profits for the drug industry, including kickbacks to the doctors
> who prescribe these drugs.
>
> For example, the cancer drug Avastin costs $100,000 per year and
> prolongs life by about 2 months. It costs a fraction of that to produce.
> It is hyped by a huge advertisement campaign and then sold to desperate,
> dying cancer patients who are grasping at straws.
>
> The movement in computer science that comes under the generic heading
> Liinux is basically an attempt to keep prices for computer software
> much lower than they are now for Microsoft and Apple software products.
>
>
> It is based on the reasonable theory that the computer scientists
> who invented the programs used by Microsoft, Apple and other large
> companies, should make a very good living for their discoveries but,
> as in the past, they should donate their scientific discoveries to
> the public domain. (Think of the Theory of Relativity or the Salk
> vaccine.)
>
> Drugs should also be considered scientific discoveries to be donated
> to the public domain. That is NOT socialism either, by the way, any
> more than it is socialism to believe that the mathematics used in
> Relativity Theory should be owned by the public and should be available
> to all scientists for free.
>
> I wonder when they will announce that we are going to have to pay
> some large corporation royalties every time we use algebra? It would
> do wonders for education ;)
Wells Fargo's Record Quarter - Really? [View article]
On Apr 09 03:37 PM eddie shore wrote:
> so we gift WFC 25B interest free and they come up with a 3B profit.
> now everyone is dancing in the street? just wait till AIG eeks out
> a profit. i cant believe people are buying this crap. time to go
> short
The Geithner Plan FAQ [View article]
I understand economics. I think this is only reasonable plan (try) we have at the moment, better than the far right who want the banking system fail while ignore the much higher cost to the country and world, and the far left who want to nationalize the banking system while ignore the fact the government is no better at running business than private companies.
On Mar 22 12:08 PM Steve in Greensboro wrote:
> Nobody who understands economics thinks this mess will work.
Will Someone Remove Geithner from the Poker Table, Please? [View article]
On Mar 22 11:55 AM punditobserver wrote:
> This article and following comments come off as the rantings of losers
> and fools who dont know what they are talking about.
>
> Someone has to say it.
How Will the Geithner Plan for Banks Ever Get Approved? [View article]
As of
"We're way past the point at which lawmakers trust Treasury to know what it's doing: they've done that in the recent past, with disastrous results, and they're not going to do it again. ",
who the hell trust congress any way? Congress should hike tax on their salary as much as AIG bonus because they approved the budget throughout the years ended up tax payer more than $10 trillion debt! They suddenly act like they really care about tax payer money.
Why It's Actually Different This Time [View article]
1. Japan had trade surplus, true, but they did have quite large government debt, as percentage of GDP, comparable to US if not more.
2. Japan's asset bubble was much larger in size percentage wise. Our housing market down 20-30%, theirs down 80-100% then more. Thus there was a huge difference in magnitude.
3. Japanese consumers wouldn't spend. They save 30-40%. As pessimestic as most people here are today, our decline of consumption is so small percentage wise relative to Japan. US consumers will never be like Japanese consumers. It's culture difference.
4. 90s was global boom, true. However, it was uncertain era for Japan due to the rise of China. China replaced many Japanese exports, which had forced Japan to change their economy significantly. Japan used to have life time job gurantee, but no more. The rise of China was negative to Japan in 90s.
On Mar 13 01:25 AM SB-tiger wrote:
>
> Japan: in the 90s Japan tried every possible stimulus program – abut
> one each year for a decade, almost paved the entire country side.
> Nothing worked, it simply produced deflation. Japan had a lot of
> things going for it – trade surplus, huge domestic savings, 90s was
> the era of global boom – end of cold war, China, etc. We criticized
> and admonished and advised Japan against it all.
>
> Now we are going to do everything they did – zombie banks, stimulus,
> and the rest of it. We don’t have the money (unlike Japan) and this
> is the first global recession since the great depression.
>