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  • Vivus Omits FDA Rejection in Press Release Touting a Study on Its Diet Pill [View article]
    Hi Pnac,

    You raise a good point. There seems to be some debate about the use of certain words when referring to FDA actions. For instance, some say that a 483 inspection report that is issued after the FDA inspects a plant indicates a failed inspection, while others insist that it only represents an interim step in the process.

    Similarly, some say a complete response letter indicates the FDA has rejected the drug, even when the agency has signaled approval is possible if additional steps are taken. Others suggest a rejection has not taken place if approval may still occur, assuming the sponsor takes the required steps requested by the agency and the drug passes muster.

    To some, this is semantics. To others, it is not, and I understand why. Generally, I use the word rejected because the drug has not yet been approved. This is not meant to suggest the FDA may have slammed the door shut on an application. If the agency has indicated approval may be forthcoming if certain steps are taken, I note that when first reporting the issuance of a letter.

    I understand you may disagree, but I responded in hopes of explaining what I have written to this point.

    Regards
    Ed at Pharmalot
    Apr 15, 2011. 08:38 AM | Likes Like |Link to Comment
  • MannKind's Afrezza Dealt Setback by FDA [View article]
    Hello Folks,

    Thanks for all of the polite comments :)

    As a journalist, I have always read Wall Street analyst reports for news and insights. I chose to post this item on Pharmalot - a web site that tracks the pharmaceutical industry and which was once owned by The Star-Ledger of New Jersey, where I worked for 15 years - because Hapoalim's LeCroy raised an interesting possibility.

    Given the on-and-off controversy over the fate of Afrezza and some of the skepticism over the way MannKind has communicated with the investing public, this was one more potential bump on the road. It was in that context in which I chose to view this as worth noting. As an aside, Seeking Alpha, which regularly grabs some Pharmalot items, ran this before I had an opportunity to add an update (in bold) at the bottom of the post to say the meeting was rescheduled for May.

    In any event, I appreciate the passion with which some investors read about their holdings. And debate can be inspirational. Thanks for stopping by.

    Ed at Pharmalot
    Apr 13, 2011. 08:13 AM | Likes Like |Link to Comment
  • Patients Try Again to Break Genzyme Drug Patent [View article]
    Dear Sune,

    What is it that you do not believe? I am simply reporting that these patients are petitioning the NIH and the contentions contained in their petition. As a journalist, that is what I do. As an aside, neither the patients nor their attorney indicated anywhere in their documents that Fabrazyme is not a desirable drug. Perhaps you should read this more closely.

    Hope this helps,
    Regards
    Ed at Pharmalot
    Apr 8, 2011. 08:24 AM | Likes Like |Link to Comment
  • Yet Another Johnson & Johnson Recall [View article]
    Hi Folks,

    Thanks for your notes. Yes, Walt17, you're correct - J&J is reorganizating McNeil, which I reported here on my Pharmalot site yesterday...

    www.pharmalot.com/2011.../

    Unfortunately, Seeking Alpha did not pick that up, even though it contained details about the musical chairs among executives. However, I have been tracking the numerous recalls - on Pharmalot - to underscore the magnitude of the problems facing J&J. I understand some may tire of the topic, but it persists and speaks to the difficulties that prompted the FDA and others to scrutinize the company.

    And to Football Frank, I don't own the stock or the stock of other companies I write about. As a journalist, I avoid doing so because that would be a conflict. As to the J&J coverage, this reflects the mounting problems. Pharmalot covers the pharma industry and its many issues, and the J&J recall mess is of considerable interest for various reasons - regulatory policy, corporate behavior, boardroom thinking, consumer reaction, manufacturing procedures. There are many implications.

    When things turn around, Pharmalot will have items on the site about those developments as well.

    Hope this helps,
    Ed S / Pharmalot editor
    Mar 31, 2011. 04:35 PM | 5 Likes Like |Link to Comment
  • KV Pharmaceuticals Under Federal Scrutiny for Price Gouging [View article]
    Hi Folks,

    Thanks for your thoughts. For those concerned with the headline, this item first appeared on Pharmalot, as do my other items, but had a different headline that read: 'Senators Ask FTC To Probe KV For Price Gouging.'

    www.pharmalot.com/2011.../

    And if you please read closely, I did not offer my opinion about this controversy. I simply reported that these senators made this request with links to background by way of earlier stories.

    I hope that helps,

    Ed S
    Mar 21, 2011. 09:24 AM | Likes Like |Link to Comment
  • Which Drugmaker Fails Most FDA Inspections? [View article]
    Hi Folks,

    For those asking about the definition of 'failed,' and to Boozer, who appears to have failed to do his or her own research about Pharmalot, here is my reply:

    First, as the item notes, it was reported by Bloomberg News, which gathered the info from the FDA by filing a Freedom of Information Act request. I ran this piece on Pharmalot, the site I have overseen for four years tracking the pharmaceutical industry. You can see it here:

    www.pharmalot.com/2011.../

    Unfortunately, I was unable to add a direct link to the original Bloomberg story because it was not made available to the wider public, unlike most pieces run by the news service. But I did receive the complete story along with clearance to run a summarized version.

    For those who may think I am an analyst, the answer is no. I am a journalist who has covered pharma for more than 15 years, starting at The Star-Ledger of New Jersey and, again, more recently on Pharmalot (you can click the 'about' tab on Pharmalot to read more if you wish).

    Pharmalot operates much like a newspaper - there is a mix of original reporting and aggregation. In short, the site includes items from elsewhere, much like a newspaper runs a story from the Associated Press or Reuters or Bloomberg. Again, this item and the graph came from Bloomberg, which is duly noted several times, and in my capacity as editor, I condensed and summarized. I did not add my own opinion or interpretation.

    If you look at the comments made on Pharmalot regarding this item, you will see that others also asked about the definition of failure. So I subsequently asked one of the Bloomberg writers, who told me they used the issuance of a 483 for their article. I noted this in the comments section myself. This sparked a debate about whether it was appropriate to use a 483 for this purpose.

    Again, please read the comments. I subsequently asked the FDA to provide some clarity and I await a response.

    Meanwhile, the debate centered on the extent to which it was proper to use a 483 as a way to determine a plant either failed to remain in compliance or failed to pass an inspection or did not fail anything. There were positions taken on all sides, which you can read for yourselves, as some argued there are clear distinctions about failure and others saying this was, in part, about semantics.

    For those of you who are not aware, Seeking Alpha runs some Pharmalot items as they appear on the Pharmalot site, but does not include a link to the site. Unfortunately, if you are not familiar with Pharmalot or do not visit the site yourself, you may miss discussions that can help clarify certain issues. I do my best to check back here to answer questions - as I am doing now.

    I hope this helps. And I appreciate probing questions and facts that correct the record. There is no need, however, to make unwarranted attacks, especially when it is rather easy to determine how these items (which newspapers still call stories) are assembled and how I go about my work.

    Regards
    ed
    Mar 7, 2011. 08:27 AM | Likes Like |Link to Comment
  • Earnings Setback for MannKind: Frozen in Tracks Over Afrezza? [View article]
    Hi Folks,

    And thanks for your responses. Just one further aside. My original post quoted both Mann and the cfo directly from the transcript of the conference call held the other day, not analysts. In other words, he said what he said. His clarification suggests, perhaps, that he belatedly recognized the impression he created. What he does next, well, I will not speculate. Anyway, I appreciate the dialogue.

    Regards
    ed
    Feb 16, 2011. 08:09 AM | Likes Like |Link to Comment
  • Earnings Setback for MannKind: Frozen in Tracks Over Afrezza? [View article]
    Hi Darth, Kruk and SS Cutchen,

    Thanks for your notes and I understand your points. I agree that Mann did not rule out further investment and yes, the cfo, indicated there may be other options, although these were not articulated. The point I attempted to make, however, is whether Mann's remark inspired confidence among investors. He says he remains committed to the project, but he must know how his words will resonate. Mann may well come through with more funds or find a way to leverage something so the company can raise additional capital. But if he is not willing to publicly commit more money at this time, would you? I think this is a reasonable topic for discussion under the circumstances.

    Regards
    ed
    Feb 15, 2011. 09:14 AM | 1 Like Like |Link to Comment
  • Are J&J Recalls Turning Off Consumers? [View article]
    Dear Richjoy403,

    Thanks for the interesting comments. For the record, a factual list of all JNJ recall problems was also provided in the first graph of this post - click on the fourth 'here' and you will find an earlier item that includes a link taking one to the FDA site listing all of the various recalls. In general, the links I provide offer background that is meant to be helpful and save time rummaging around for info.

    As to the timing of the release, it is an old practice for companies to release bad news at what is considered a slow news moment. Even in this Internet era, a late Friday afternoon at the start of a holiday weekend would be considered a typical example of a company engaging in such a practice. And this was highlighted in this post, because it would appear to contradict the level of transparency with which JNJ has recently insisted it is handling this series of gaffes.

    Regards
    Ed
    Jan 18, 2011. 10:33 AM | 1 Like Like |Link to Comment
  • Novartis Sales Force Job Eliminations a Cause for Concern [View article]
    Hi Elliot,

    Thanks for your note. First, I'd like to point out that I did not write the headline. An editor did so. (Although as for concern, when it comes to sales reps, there is concern; for investors, probably less so, or none at all). And I pointed to CafePharma for the very reason you cited - its not an impartial source, but an online forum - not a blog - where sales rep discuss issues that affect them. I directed readers there to get some insight into the concerns that sales reps had been expressing recently.

    Hope this helps,
    ed
    Dec 2, 2010. 07:51 AM | Likes Like |Link to Comment
  • Merck Investors Pleasantly Surprised, Despite Vytorin Scandal (Part II) [View article]
    Hi John,

    Thanks for the note and good point. I should have noted that, even though Nissen singled out those results, those particular findings were not statistically significant.

    Regards
    Ed
    Nov 25, 2010. 12:24 PM | Likes Like |Link to Comment
  • Siga Technologies: When Is a Small Biotech Really Not So Small? [View article]
    Dear Bitoechguru and Divineintervention,

    Thanks for sharing your thoughts. If you read my post carefully, you will see that I did not take a position. Some items on Seeking Alpha do and some don't. Some writers do so more than others. In this case, I reported what was out there for my Pharmalot site and the item also ran here. I offered no opinion on what transpired or what might ensue. Feel free to take your whacks - I enjoy give and take as much as anyone - but your assumptions that I somehow support one outcome or the other are incorrect.

    Regards
    Ed S
    Nov 9, 2010. 08:08 AM | Likes Like |Link to Comment
  • Arena's 'Fat Chance' for Drug Approval: No Surprises There [View article]
    Hi Gaucho,

    Thanks for your note. First, you seem to have confused The Pink Sheet, a pharmaceutical industry newsletter and web site for which I used to work, with the Pink Sheets, the quotation system for low-priced OTC stocks. So before you make assumptions, please check things out. And no, I'm not on anyone's 'payroll.' If you did check my bio, you'll see that I'm a journalist with a long track record of working for reputable publications, and I currently work for United Business Media, for which I edit Pharmalot and also serve as an editor-at-large for a couple of other titles - MedAd News and R&D Directions.

    As to your other points, I noted that the FDA does, in fact, want results of a trial in patients with diabetes. That's in the first paragraph. And I also noted the FDA wants more evidence about the tumors in rats. I'm not sure how you interpreted my brief summary as unbalanced, though. I simply stated what Arena indicated in its press release. Yes, the timing for the final outcome is debatable, although I think it's reasonable that we may not see a decision for some time. If it happens sooner than later, well, fine.

    Nonetheless, this occurs in the context of an agency that is, for better or worse, harping much more on safety these past couple of years. I understand your point about having - or not having - a toxicologist on the advisory committee. But the diet pill was reviewed in the wider context of safety issues, which has haunted numerous drugs but especially those to treat obesity. I don't think that's surprising and that was the only point I was trying to make. That's not the same thing as expressing my own view about the safety of the Arena pill or the agency's motives for reaching its recent decisions. Hopefully, this difference can be grasped.

    Regards
    Ed S
    Oct 24, 2010. 11:21 AM | 5 Likes Like |Link to Comment
  • Johnson & Johnson's Reputation Begins to Slide [View article]
    Dear Boozer and Captain Spaulding,

    You make fair points about sample size, but again, as I indicated the results offer a snapshot and, therefore, were worth reporting. There are almost always limitations regarding studies and surveys. Such disclaimers are par for the course, but that does not automatically invalidate the insights that can be gleaned. And yes, in my view, the analyst is reputable and has been following pharma and biotech for many years. And for the record, the first question asked was: Were you aware of the J&J product recalls earlier this year? In any event, it is time for me to move on.
    Oct 3, 2010. 05:37 PM | Likes Like |Link to Comment
  • Johnson & Johnson's Reputation Begins to Slide [View article]
    Dear Boozer and MC,

    I chose to write about this survey on Pharmalot because the survey - despite any limitations on sample size or debates about the questions asked - was conducted on behalf of a reputable analyst. It was not released to the public, but only to the firm's clients and select journalists, including me.

    Feel free to disagree with the methodolgy - that in itself is up for discussion. But the findings offer a snapshot of a controversial and important issue, and for that reason I felt it was worth coverage.

    As for the 'sloppy' writing, if you look closely, you will see that the reference to the survey and the analyst appears in the second paragraph. Feel free to criticize, but please read closely before dashing off incorrect remarks.

    Regards
    Ed at Pharmalot
    Sep 30, 2010. 08:26 AM | 3 Likes Like |Link to Comment
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