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  • Arena's Belviq Does Not Fare Well With Consumer Reports  [View article]
    You wrote "For the most part the obesity issue can be tied to a lack of discipline."
    That is nothing more than an unsubstantiated and biased opinion from someone who has obviously done little or no research into the science .
    Jun 14, 2013. 03:24 AM | 15 Likes Like |Link to Comment
  • Arena's Belviq Does Not Fare Well With Consumer Reports  [View article]
    The CR blurb about Belviq was very unscientific, and very misleadingly simplistic. For example, it contained nothing about the statistical distinctions among the various levels of response. As far as the CR article is concerned, I say "skip it," and ask your doctor's advice instead.

    The CR article is based on the same extraordinarily uninformed and dismissive and simplistic premise: people should lose weight through diet and exercise. This idiocy - usually promoted by gym and/or diet control extremists in their 20's or 30's - indicates a complete lack of understanding of how hard it is for an obese person to stick to a diet when for years that persons' brain (and gut) have been trained to crave simple carbs. Belviq provides that additional help needed by the obese to stick it out. How hard is this to comprehend, Spencer?

    By the way, what were your real reasons for choosing (it was your choice) to write an SA article drawing attention to this silly CR blurb? Personally, I think your credibility is subject to question when you state that you are long Arena.
    Jun 14, 2013. 03:10 AM | 9 Likes Like |Link to Comment
  • A Study Of Arena's Lorcaserin Against The Backdrop Of Several Anti-Obesity Mechanisms  [View article]
    Some important points need to be made on this issue:

    -During the trials the placebo group had an unexpectedly low incidence of valvuopathy;

    -Losing significant weight (as some clinical patients did) can itself cause valvuopathy, so it is not surprising that the placebo arm of a diet drug trial would come in with a lower incidence..

    I am certain the FDA took the above into account when they decided not to impose a REMS, but to require post-marketing studies that will study the valvuopathy issue further.

    From what I have read, valvular regurgitation develops gradually and can be picked up early with regular steth exams (I believe physicians are supposed to do regular steth exams on Belviq patients). Also, from what I have read about valvuopathy and diet drugs generally, the condition regresses when the drug is stopped.
    Jun 4, 2013. 11:34 PM | 1 Like Like |Link to Comment
  • Arena To Offer Quarterly Results - What Investors Need To Hear  [View article]
    I am not asking Arena to speculate on timing, only to provide material facts about procedural milestones or other events that have already happened or about things that they know - know - about events yet to come..

    Apr 30, 2013. 04:28 AM | Likes Like |Link to Comment
  • Arena To Offer Quarterly Results - What Investors Need To Hear  [View article]
    In addition to the above, I believe ARNA should answer the following questions regarding the EMA/CHMP process:

    1. Have you presented an oral explanation to the CHMP?
    2. If you have made that presentation, was there a trend vote?
    3. If there was a trend vote, was it positive or negative?
    4. If you have not yet presented the oral explanation, do you know whether you will be making such a presentation?
    5. If yes, has a date been scheduled?

    The answers to these questions do not require Arena to speculate. Nor do the answers require forward-looking statements. Arena should just disclose the basic material facts about any procedural milestone event that has passed. As for the trend vote, if there has been one, Arena should disclose whether it was positive or negative,but simultaneously issue a word of caution that a trend vote does not necessarily determine what the final CHMP recommendation will be or when it will be issued. Right now, if there has been an oral explanation and a trend vote, that is highly material information that is known to a large number of people; probably not at Arena but at the CHMP and the EMA. The risk of significant leaks between now and the end of the next CHMP meeting is therefore very high, which means that opportunities for insider trading and manipulation are also high. ARNA should level the playing field by just disclosing the material facts about these milestone events.

    I strongly believe that if an oral presentation has been made, that should be disclosed. If a trend vote occurred, that should also be disclosed along with a statement about whether it was positive or negative.. As noted, these are highly material milestone events in this process; and, IMO, ARNA should be disclosing all material information about these events.
    Apr 29, 2013. 04:31 AM | 9 Likes Like |Link to Comment
  • Arena Faces A Convergence Of DEA And European Decisions  [View article]
    Based on everything I have looked at (which is actually quite a bit), IMO:
    -DEA scheduling by May 10, but earlier is likely; could even be before the end of April.
    -CHMP opinion either this Friday or on May 31 (no later than that), with the odds favoring this Friday.
    Apr 24, 2013. 07:25 AM | 5 Likes Like |Link to Comment
  • Arena Faces A Convergence Of DEA And European Decisions  [View article]
    Here we go again. When will Seeking Alpha authors learn to get their facts straight. There was no "second 180 day List of Outstanding Issues (LoOI)". What you are trying to refer to is the Day 180 (not 180 day) List of Outstanding Issues. Arena received one - and only one - such list. On January 18. They responded "in February"; we know this because this is what Audet stated in the early March conference call.

    As for the speculation by you and others that Belviq will not sell well in Europe. That is speculation. Nothing more. Arena will almost certainly partner with a European heavyweight like Roche, and that partner will carry the ball on marketing and pushing the reimbursement issue. Personally I think you and that other article writer are now substantially underestimating the demand for Belviq in Europe.
    Apr 24, 2013. 06:39 AM | 7 Likes Like |Link to Comment
  • Arena Pharma Has Plump Profit Potential  [View article]
    Todd, the point of my post was to point out a few of the misstatements in your article. I would have thought that you would have focused on correcting those errors rather than asking questions about my personal views. I accept that your focus is on making money, but I don't know how you can succeed at that without first really understanding facts that are critical to the company's business. .

    And I find amateurish your response "We all know the issues you state..." Really? Then why did you get it so wrong? Is it because writing truly useful articles requires too much research and analysis?
    Mar 18, 2013. 03:19 PM | 5 Likes Like |Link to Comment
  • Arena Pharma Has Plump Profit Potential  [View article]
    Not to mention that "massive global demand" is what we want. I believe - although I am no MBA - that Arena intends to make a profit. So, yes, "massive global demand" will increase Arena's manufacturing, marketing and distribution costs, but these costs will be rolled into the price of the pill along with Arena's margin. And there are economies of scale involved. So "massive global demand" should mean - if ARNA intends to make a profit - that Arena will actually end up making more profit on each additional pill it sells.
    Mar 14, 2013. 09:41 AM | 3 Likes Like |Link to Comment
  • Arena Pharma Has Plump Profit Potential  [View article]
    Mr. Johnson, on European approval you wrote:

    "In January 2013, Arena Pharmaceuticals stock decreased modestly on concerns over approval by the European Medicines Agency which released statements saying Belviq was possibly linked to tumors and undesirable psychiatric side effects observed by Europe's Committee for Medicinal Products for Human Use. If Arena Pharmaceuticals hopes to expand in Europe, it must genuinely prove these concerns to be false."

    This is simply inaccurate. The EMA has "released" no such statement about Belviq. Nor has the EMA's Committee for Medicinal Products for Human Use (the "CHMP") "observed" any side effects of Belviq.

    What the CHMP did do is provide ARNA with the standard list of outstanding issues on Day 180 of the process. The purpose of that list (which is not a public document at this time) is to advise the drug sponsor (in this case, Arena) of the major outstanding issues (which are technically referred to as "objections") that the sponsor must still address before the CHMP will proceed to issue its opinion on the marketing application. That opinion is - for all practical purposes in the vast majority of cases - the decisive document. While it is true that the European Commission (EC) must subsequently issue the formal approval or disapproval (within 60-90 days); I have been so far unable to identify a single instance where the EC has failed to follow the CHMP's recommendation; but this does not mean there is not such a case.

    Back to list of outstanding issues received by Arena on January 18.
    Arena - not the EMA - made the following statement:

    "We have received the Day 180 List of Outstanding Issues from the ...CHMP. The issues will need to be addressed before the CHMP can recommend BELVIQ for marketing approval in the EU. The major objections relate to previously identified non-clinical and clinical issues, including tumors in rats, valvulopathy and psychiatric events, and the CHMP requests that we further justify BELVIQ’s overall benefit-risk balance taking these issues into consideration."

    From the above it is clear that Arena is not being required, as you erroneously wrote, to "genuinely prove these concerns to be false."
    Proving that a concern is "false" would be an insurmountable hurdle for any drug sponsor. The analysis is a far more sophisticated one:
    Arena is being required to justify the overall benefits of the drug in relation to the risks. What Arena must do is provide the CHMP with scientific evidence that allows the CHMP to accurately assess (i) the real risk potential (Arena did this very successfully with the FDA; that is why Belviq is not subject to a REMS requirement), and (ii) the overall public benefits.

    Consequently, Arena stated further that "In accordance with the CHMP’s process, we have been asked to address the issues in writing. The CHMP also plans to consult with independent experts who will provide recommendations on the outstanding issues. In addition to the written response, we have been invited by the CHMP to provide an oral explanation."

    Typically, written responses to the list of outstanding issues must be received within 30 days. The list was issued on January 18, and Arena has stated that it provided written responses in February. This is consistent with the normal process. Now the big question is whether Arena will still be required to make an oral presentation. Normally such an oral presentation is scheduled within 30 days after the written responses have been submitted. But Arena has recently stated that they don't know whether they are still going to have to provide an oral presentation.

    Why is this a big issue? Because when an oral presentation is required, the 210 day clock only begins to run again when the oral presentation is made. If the oral presentation requirement is dropped, I believe that the clock would start to run again on the day the requirement is dropped.

    The CHMP's March meeting is next week. If Arena is making an oral presentation, there is a very high probability that that presentation will happen next week. If the oral presentation requirement has been dropped (and Arena should know that by now), there is a significant possibility that the CHMP could simply adopt its opinion, which would be published on March 22. Personally, I think the CHMP has asked Arena to present next week, if for no other reason than to avoid having to deal with an issue about when the clock should restart. So I am looking for the CHMP's opinion at the end of its April meeting, but I am not ruling out the possibility that it could be published next Friday.
    Mar 14, 2013. 02:19 AM | 13 Likes Like |Link to Comment
  • Arena Pharmaceuticals' Diet Drug Drama A Nail Biter  [View article]
    BTW, I just checked the Federal Register for today (March 7), nothing about Belviq.
    Today is Day 48 since the close of the public comment period. The average number of days between the close of the public comment period and the publication of the final scheduling rule appears to be about 45 days.
    Mar 7, 2013. 03:19 AM | 9 Likes Like |Link to Comment
  • Arena Pharmaceuticals' Diet Drug Drama A Nail Biter  [View article]
    The FDA did not classify/schedule Belviq. They suggested - suggested - that the DEA classify it as Schedule IV. The DEA then does its own independent review, taking the the FDA's recommendation into consideration.

    Whenever an author gets small but important details like this wrong (and that happens very very often on SA), it undermines the credibility of the author on pretty much everything else in the article.

    Take for example this sentence: "While approval in Europe appears to be a long way off or even a non-starter, Belviq is more likely than not to be sold in the U.S. - perhaps the largest market for diet drugs."

    "Belviq is more likely than not to be sold in the US...."?? Actually, Belviq will in fact be sold in the US. It has been approved by the FDA;, it is only waiting for the final scheduling rule from the DEA, which could be published in the Federal Register any day. Normally such a rule only takes effect 30 days after publication, but Eisai has asked the FDA to waive that 30-day lag period; but we still do not know whether the DEA will grant that request.

    "While approval in Europe appears to be a long way off or even a non-starter,..."??? The major event in the european process is the CHMP's opinion, which is then followed by a final decision of the European Commission in 60-90 days (but the EC rarely - if ever- fails to follow the CHMP's opinion). In any case, the CHMP opinion could come out as early as as March 22, but I think April 26 is far more likely. That is not "a long way off".

    A "non-starter"? It is true that the CHMP could give Belviq a negative opinion; however, such an opinion would almost certainly be based on the CHMP's uncertainty about the available statistical data; so it would certainly be possible for Arena to reapply after it has obtained more statistical data from its experience in the US.

    Mar 7, 2013. 02:25 AM | 13 Likes Like |Link to Comment
  • Arena Pharmaceuticals Outlines Its Path To Profitability  [View article]
    Thank you for pointing out that information. However, I don't think it detracts from the fundamental point that - regardless of what price they paid - as of the end of September 98 million shares, or 45% of the OS, were being held by institutions. That is an increase of about 11.5%, or 24 million shares over the previous end of quarter figures.

    And I think it is reasonable to believe that at least some significant number of the shares distributed on those warrants have been sold before the end of September.
    Nov 19, 2012. 09:00 AM | 1 Like Like |Link to Comment
  • Arena's Big Move: What's Behind It?  [View article]
    There is one problem with the article. It states that after the notice of proposed rule-making, "the process would still entail at least another 60 days before BELVIQ's final scheduling would take effect."

    A 60 day difference between the publication of the proposed scheduling rule and the effective date of the final rule is the absolute theoretical minimum. It assumes that no public comments are submitted and that the DEA immediately publishes the final rule as soon as the public comment period is over. This has never happened. After the close of the 30 day public comment period, the DEA will need - looking at past schedulings as a guide - a minimum of 20 days (and that would be an outlier) to review and summarize the comments and to prepare and publish the final rule, which then becomes effective only after the passage of another 30 days.

    Therefore, in practice, the absolute minimum amount of time between the publication of the notice of proposed rule-making and the effective date of the final rule would be about 80 days. But, again, that is the bare minimum. A more realistic projection would be about 105 days.
    Nov 18, 2012. 12:50 AM | Likes Like |Link to Comment
  • Arena Pharmaceuticals Outlines Its Path To Profitability  [View article]
    Lessons learned from the ARNA experience:

    1. Pay no attention to what Cramer and The Street say about anything. It certainly appears to me that they have an agenda and that helping retail is not on it.

    2. Pay no attention to the other analysts. Just read the obviously uninformed, and ridiculously irrational opinions put out by CS and BoA about ARNA. They definitely have an agenda, and it is not to help retail. Besides, I have yet to read one analyst opinion about any company in the biotech space that has been properly and thoroughly researched. They all shoot from the hip without much thought or understanding. I guess doing proper research is just too hard and time-consuming and it requires too much critical thinking. I'm pretty certain these guys were not top of their class and had an aversion to the library when they were in school.
    Nov 17, 2012. 09:04 AM | 2 Likes Like |Link to Comment