ARNA shareholders filed a lawsuit against Adam Feuerstein of thestreet.com
http://www.thestreet.com/story/11489090/1/vivus-obesity-drug-delay-is-good-and-still-means-arena-pharma-rejection.html
Link to defamatory lawsuit
http://www.jdlawfirm.org/uploads/3/0/6/0/3060978/letter_to_adam_feuerstein_to_cease_and_desist_from_making_false_fraudulent_and_defamatory_statements.pdf
Some informative and interesting comments in response to AF's blog post
andybaron - Adam, please take a few minutes to do some DD on Arena. A good place to start is their last 10-K; the discussion of the new data they've submitted to the FDA begins on page 5. You'll learn that a group of 5 pathologists, chosen by Arena and the FDA, found no increase in malignant mammary tumors over placebo except in the highest dosage group of rats that received 82 times recommended human dose.
Benign mammary tumors were increased in rats at all dosages. You can quibble over whether Arena was able to present convincing evidence that this was mediated by prolactin, which causes tumors in rats but not humans. I think the evidence was convincing, especially because blocking prolactin also eliminated tumor formation. But, in any case, the FDA did not express any concern over benign tumors, which do not progress to malignant tumors and present no serious health risk in humans.
It is true that mean placebo-adjusted weight loss was only about 3%, but that is partly because the placebo group did very well, and also because this includes those who dropped out of the study (as in all weight loss studies to date, about half the patients dropped out before completing the study). The weight loss for those who completed the studies averaged about 8% for those taking lorcaserin, and all the measured bio markers for CV and glycemic health improved significantly over placebo. The weight loss for Qnexa completers taking the recommended middle dose was only about 2% higher, and their bio marker improvements were no better, or worse -- although a head-to-head study would be needed for a meaningful comparison.
Lorcaserin has been proved to be highly selective for the 5-HT2C receptor, which affects satiety, over the 5-HT2B receptor, which affects heart valves. Echo-cardiograms performed on all 8000 of the patients in Arena's phase III studies showed no evidence of increased valvulopathy in those taking lorcaserin. On the other hand, fenfluramine had greater affinity for the B receptor. And, by the way, fenfluramine caused no more weight loss than lorcaserin when taken alone, even though fen-phen caused more weight loss than Qnexa.
These facts are readily available and have been presented to you many times. I'm frankly baffled about why you refuse to acknowledge them.
phillydan55 - Adam, Adam, again with the heart valve damage. There is none. You allude to data when you want to make your efficacy argument but when it comes to the valvulopathy issue, you ignore the data of the results from the study. Again, since you like to talk placebo, basically the placebo group had just as many instances of VHD as the drug group across all three studies. In addition, the percentage of patients showing a signal for VHD disease in both the placebo and drug groups was a bit over 2%, which is below the percentage for the general population.
The FDA never raised VHD as an issue in their CRL to Arena. Yes, fen is a distant cousin like maybe a 10th or 12th cousin. The truth is that Fen is known to affect several of the 2x receptors and particularly liked the 2B receptor which is the receptor identified by real scientists that caused the valvulopathy in people taking Fen-Phen. Lorcaserin has been shown in several studies that is has little to no affinity for the 2B receptor, in fact 104 fold.
Back to the efficacy. You always keep forgetting to mention the fact that lorcaserin did meet the FDA's defined guidelines for efficacy. Talk the placebo adjusted tango, all you want but lorcaserin is proved in it's studies on a categorical basis (that other criteria the FDA uses but you seem to think doesn't exist) to have shown weight loss of 5% or greater in 48% of people in the studies and is twice the placebo amount. In addition, lorcaserin has been shown to cause a weight loss of greater than 10% in 35% of completers and 25% of completers lost 16.7% of their weight.
In addition, when approved, like Qnexa, doctors will use phen in combination with lorcaserin to achieve safer and greater weight loss than Qnexa. So take that and put it in that little pipe you keep and smoke it, yes Adam, smoke it because you and your lying article have been smoked.
It is going to be fun when you and your buddy man Gekko creep are smoked on May 10th and lastly on June 27th. Victory for the world of the obese who will now have a safe weight loss drug that will help them lose weight and for type 2 diabetics reduce their A1C levels greatly. Defeat for the evil ones like Gekko and you.
BTW, I hear you both look good in orange and maybe they will let you share a cell....LOL!
Tran - Adam your poor logic astounds me. How well did the 3-month delay go for the investors of MNKD? Just because they issued a delay does not mean they agree to approve it. You who have a job to watch these things should know that! It just means a delay. It could be a delay to figure out how to handle REMS. Or it could be a delay because, after all, they pushed OREX back at least 4 years by asking they bring CV studies before approval, and now they have to figure out how to approve Qnexa without asking the same thing. Remember OREX got a favorable panel. OREX representatives were at the Qnexa panel to express their disgust at the FDAs double standards. Or they can't figure out to make a meaningful Qnexa REMS that can be easily circumvented by taking substantial equivalent generic doses of Topamax and Phentermine? I admit I am stumped by that one too. They agreed to restrict access to the drug so severely that they will encourage MDs to write the generic components. Maybe they have to decide whether to lift the stricture on Phentermine? Remember the FDA asks doctors to limit Phentermine administration to 12 weeks maximum. But with Qnexa people will take it for years. What should they do about Phentermine monotherapy? Expand access or be hypocrites and leave it as is? And if they expand access, what does that say about their so called "concern for the welfare of patients"? Isn't the reasons they put restrictions on Phentermine because of CV issues? So why suddenly should they fall in love with a drug that gets all of its kick from Phentermine? Seriously. The Qnexa trials were not well powered, nor did they even test for, CV issues. They split the drug into 3 doses and split the trials into 4 (high dose, mid dose, low dose, placebo) so there is no way they were powered well to determine serious AEs. If 1 in 1000 have heart attacks (as some did on the Qnexa trial) how will they know? One person on the panel questioned their methodology, eg the high rate of dropouts could be because of increased Heart Rate, thereby giving bias to the results. Combined with such small trials it is inconsciounable that they approve Qnexa without more aggressive CV testing.
TomJones45 - From Mo_Money_2make on IV board" Yes.
Adam is wrong as much as he is right.
This mornings piece is nothing more than a quick poke to ARNA longs
and fuel to light VVUS up. Hedge fund friends of Adam are making some
coin playing the volatility. He is so confident that a 3-mo delay =
approval but he has no clue. MNKD's 3-mo delay resulted in a CRL. It
just means the FDA hasn't figured out how to approve it with a complete
REMS. Will they approve it in 3-mo? Maybe or Maybe Not. Adam has no
clue and the FDA probably doesn't definitevely know yet. I think
Colman wants it approved but they still have to come up with a
reasonable REMS. Not an easy task.
Adam's
comments around ARNA speak for themselves. He believes ARNA causes
tumor in rats. He also just looks at the 3% placebo adjusted ITT-LOCF
mean weight loss but doesn't mention the positive improvements on
co-morbiity factors particularly the impact for diabetics.
But
the FDA may not either. They may still just focus on the 3% placebo
adjusted number and don't care about the rest. Even though it meets
their guidelines, they may not want another weight loss drug approved
even with pressure to approve one. None of us knows until it happens
and that is why the stock trades like it does and will go up 300% from
here with a positive AdCom or crash by 80% without one.
AF
doesn't deserve responding too. He doesn't give balanced reporting at
all and as such, has little credibility except with some real
investors. Bank of America, Goldman, Wells, Morgan Stanley, Jefferies,
etc. put ZERO weight into what AF has to say as do the hedge funds that
are trading ARNA. Retail shouldn't either."
Adam is wrong as much as he is right.
This mornings piece is nothing more than a quick poke to ARNA longs
and fuel to light VVUS up. Hedge fund friends of Adam are making some
coin playing the volatility. He is so confident that a 3-mo delay =
approval but he has no clue. MNKD's 3-mo delay resulted in a CRL. It
just means the FDA hasn't figured out how to approve it with a complete
REMS. Will they approve it in 3-mo? Maybe or Maybe Not. Adam has no
clue and the FDA probably doesn't definitevely know yet. I think
Colman wants it approved but they still have to come up with a
reasonable REMS. Not an easy task.
Adam's
comments around ARNA speak for themselves. He believes ARNA causes
tumor in rats. He also just looks at the 3% placebo adjusted ITT-LOCF
mean weight loss but doesn't mention the positive improvements on
co-morbiity factors particularly the impact for diabetics.
But
the FDA may not either. They may still just focus on the 3% placebo
adjusted number and don't care about the rest. Even though it meets
their guidelines, they may not want another weight loss drug approved
even with pressure to approve one. None of us knows until it happens
and that is why the stock trades like it does and will go up 300% from
here with a positive AdCom or crash by 80% without one.
AF
doesn't deserve responding too. He doesn't give balanced reporting at
all and as such, has little credibility except with some real
investors. Bank of America, Goldman, Wells, Morgan Stanley, Jefferies,
etc. put ZERO weight into what AF has to say as do the hedge funds that
are trading ARNA. Retail shouldn't either."
catfishcoon - Just a simple question for you adam. If you are married, and your wife was childbearing age, and obese, and there was 2 different pills that could offer help , one of which worked slowly, and the desired weight loss could be lost in 12 months, and that pill was safe with no side effects, the other pill worked quicker, and the desired weight loss could be achieved in 6 months, however, with that pill, there was a potential of serious side effects that could harm the person taking it and also harm the fetus. Which of these would you advise your wife to take?
murry - Hey Adam,
Congrats on your call (or your "institutional traders" call) on a qnexa delay/ extension for fda rems review. It was spot on! I do find it a little strange that your trader seemed to have had that info (hunch) before the rest of the investment community. Maybe it was a good guess, maybe not. This is why the majority of people are scared to death of the stock market and feel that its totally rigged and the big houses are the only ones that make money at the expense of the individual investor. Big institutional traders seem to always have great info before the general public.
I do follow you (as many do based on the fact that arna tanked today on your article) and I gotta admit I am a little shocked by how absolutely positive you seem to be regarding ARNA being denied. I must admit I sold my Arna I had this morning immediately after reading this article and the previous article on top fda approval gurus opinions on vvus approval. Loved the bonus question at the end of that article asking if the guru's felt arna would be approved. Just not sure why it was included.
The timing is curious, only because you have never really said much about ARNA until the last couple articles.
Congrats on your call (or your "institutional traders" call) on a qnexa delay/ extension for fda rems review. It was spot on! I do find it a little strange that your trader seemed to have had that info (hunch) before the rest of the investment community. Maybe it was a good guess, maybe not. This is why the majority of people are scared to death of the stock market and feel that its totally rigged and the big houses are the only ones that make money at the expense of the individual investor. Big institutional traders seem to always have great info before the general public.
I do follow you (as many do based on the fact that arna tanked today on your article) and I gotta admit I am a little shocked by how absolutely positive you seem to be regarding ARNA being denied. I must admit I sold my Arna I had this morning immediately after reading this article and the previous article on top fda approval gurus opinions on vvus approval. Loved the bonus question at the end of that article asking if the guru's felt arna would be approved. Just not sure why it was included.
The timing is curious, only because you have never really said much about ARNA until the last couple articles.
I generally respect your writing and feel that your very informative. Im just uncomfortable with this articles timing and the lack of any real stats or info to back up such a superior judgement. Im not sure if you were off when you wrote it but after reading it I really thought your column may have been hacked by someone else. Just didnt seem like your writing.
I realize that The Street in an investment web site and your job is to inform those investors but im not sure we want to know how close you are to institutional investors and their information. Not saying you did anything wrong. Just saying it does not sound kosher. Maybe Im wrong. Im sure I will thank you later for helping to convince me (been on the fence) to sell my ARNA and save $$$.
Keep em coming. Just please give us some DD to back up what your saying if your gonna make such absolute predictions.
Thanks
