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Kevin CC

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  • Chelsea Therapeutics: The Good, The Bad And The Ugly [View article]
    Interesting that the author and none of the people making comments bring up the 'obviously fabricated' data from the Ukrainian site for study 301. If you listened to the Adcom it was painfully clear the FDA knows this data is fraudulent (they do not suspect the company of any foul play though) and without it 301 was not stat sig.

    Drug may get conditional approval anyway but this issue is a huge issue people seem to be ignoring.
    Feb 13 10:53 AM | 3 Likes Like |Link to Comment
  • Sangamo Bioscience: The Impending Failure In HIV [View article]
    Good article David. I moved out of SGMO much too early but shared your view the expectations at this point are far too high.
    Mar 15 12:29 AM | Likes Like |Link to Comment
  • Anacor Knocking On The Door [View article]
    Keep in mind you don't want to look at vehicle-adjusted cure rates for this indication like you would with placebo-adjusted rates. The vehicle is still part of the treatment and it's the total cure rate podiatrists will be looking for.

    Tava is definitely approvable but it is currently inferior to IDP-108 until more data says otherwise and will come to market after IDP-108.
    Feb 21 03:44 PM | Likes Like |Link to Comment
  • Anacor Knocking On The Door [View article]
    Not really. It's possible but in the end I believe Tava is likely just inferior to IDP-108. The best thing Anacor can hope for is the FDA to uncover some blemish in the IDP-108 data but I'm a skeptic on that front too. If there is an ad-com for IDP-108 and the FDA provides a free live broadcast I'll listen in hoping to glean some new information. I'm not holding my breath though.
    Feb 19 12:48 PM | Likes Like |Link to Comment
  • Anacor Knocking On The Door [View article]
    It may very well not reach the same efficacy levels. Keep tabs on IDP108 though. It will be interesting to see what Valeant prices it at. I'm curious what your source for the 'rumor' is.
    Jan 3 12:40 PM | Likes Like |Link to Comment
  • Pfizer's Xeljanz Gets Approval, While Lilly's Baricitinib Looks Strong [View article]
    Many joke about the long list of side effects of drugs on TV commercials but some need to be reminded not everyone experiences side effects and when they do it doesn't mean they experience them all. Sounds like common sense but I'm often surprised at the number of people who don't seem to realize this.

    Thanks for reading.
    Dec 24 06:38 PM | Likes Like |Link to Comment
  • Anacor Knocking On The Door [View article]
    Lawsuit isn't big news: http://bit.ly/VPxsnJ

    Thanks deut, I also didn't go into any detail on GSK 052 being handed back to Anacor in October or their work in psoriasis (shelved till further funding comes in). The story is a nice one.

    I almost wish an advisory committee for Valeant's IDP 108 would be announced. I'd like to read the FDA's briefing documents for additional insight.
    Thanks for reading.
    Dec 18 05:23 PM | Likes Like |Link to Comment
  • Pfizer's Xeljanz Gets Approval, While Lilly's Baricitinib Looks Strong [View article]
    If by 'conditions are horrible' you're referring to the side effects of these drugs then yes, they can be. But keep in mind not all patients experience them and the relief they provide is often worth the risk. RA drugs wouldn't be billion dollar sellers if patients didn't think so.

    On bone disease progression: the drugs actually can stop progression...but not forever. Usually an RA patient will progress through a series of DMARDs because of adverse events or the drug stops working for them. I can't find the exact number in my notes but I seem to recall a patient is on an RA drug for an average of 5 to 7 years.

    The link below is to a previous article citing the FDA briefing docs (bds) about disease progression. Under 'The Surprise: Efficacy' check out #2. Link to the BDs is in first paragraph of the same section.

    http://seekingalpha.co...

    Thanks again for reading.
    Nov 25 11:55 PM | 1 Like Like |Link to Comment
  • Oral Rheumatoid Arthritis Market Remains Open As FDA Questions Efficacy Of Pfizer's Pill [View article]
    It very well may get approval but I'm wondering how big an issue the lack of radiographic data will be to the FDA. Read my most current article on tofacitinib for more details.

    I have to disagree about where tofa gets used. I suspect it will be prescribed largely after the anti-TNF blockers. Time will tell thought.

    Thanks for reading.
    Jul 22 08:01 PM | Likes Like |Link to Comment
  • Chelsea: Raising Funds While Stuck In The Muck [View article]
    The report you refer to is actually the briefing docs and are not a product of a committee but rather an FDA staffer. If memory serves her name was Dr. Melanie Blank. Typically 'panel' and 'committee' are interchangeable terms referring to the group of experts gathered to provide their expert opinions by the FDA.
    Jul 4 09:44 PM | 1 Like Like |Link to Comment
  • Chelsea: Raising Funds While Stuck In The Muck [View article]
    I'm not advocating stringing along investors so management can continue to get paid but it happens all the time. I'm actually struggling to recall a biotech that closed doors because all their compounds were lousy...which is different from closing doors because they went bankrupt.

    Also, I don't believe RNAi is a bogus space but it certainly wasn't (and still isn't) ready for primetime.
    Jul 4 01:04 PM | Likes Like |Link to Comment
  • Chelsea: Raising Funds While Stuck In The Muck [View article]
    Tmeyer: I have neither LT or ST pps in mind for HZNP. If I do buy back in it will be on a meaningful pullback. I previously bought in on a dip around 5.80 and sold in the 7s. I have absolutely no intention of holding through PDUFA. Looks like a big 'sell the news' whether approved or not. I'm beginning to focus on run-ups and staying more away from holding through defined catalysts (PDUFAs & data readouts).

    Jtricks: I do believe CHTP managements' intentions are good but they have definitely made some mistakes along the way. I don't think it necessarily makes them incompetent but it does underline their inexperience. If they fail to learn from their errors I'll happily pin the 'incompetent' label on them.
    Jul 4 10:32 AM | Likes Like |Link to Comment
  • Chelsea: A Short-Term Buying Opportunity [View article]
    I can't think of any examples where investors know the numbers of patients enrolled at individual sites. Also don't know if sites ever get told there is a limit to their enrolment numbers. Interesting question.
    May 25 06:27 PM | Likes Like |Link to Comment
  • Chelsea: A Short-Term Buying Opportunity [View article]
    301 was so statistically significant it didn't require a confirmatory trial true but the FDA making that call and deciding not to approve because of the one site are two separate decisions that are made at two different times and likely with two different sets of data (or more specific data). It's also possible the FDA changed their mind and decided they needed to be concerned about that one site.

    CHTP was aware of the one site and that is why they conducted two independent audits of the site. The FDA also conducted their own audit. No problems were found by anyone.

    I plan on sitting down and reviewing the ad-com transcript because I think FDA staffers (Temple, etc) present (beyond the one who wrote the BD) stated the length of trial was sufficient. It could be both issues resulted in the CRL. Notice the CRL suggests a trial to confirm the efficacy of 301 (the site issue) and recommend duration of 2 to 3 months (durability). I suspect the FDA would have approved Northera even with the durability question unresolved if the site issue did not exist. I think the FDA suggesting a 2 to 3 month trial in the CRL and then agreeing to something less than 8 weeks during End of Review meetings supports my belief.

    Unless the RA data is a home run (a clear benefit regarding tolerability and safety AND ACR20 in the mid to upper 60s) then I don't plan on holding till a partnership. I will sell after data release and wait till after expected dilution before considering a re-entry. That's the plan for now anyway.
    May 24 09:10 PM | Likes Like |Link to Comment
  • Chelsea: A Short-Term Buying Opportunity [View article]
    I also wanted to add that the FDA's issue with the one site in 301 is precisely because there is only one trial required by them. I didn't include it in the article but the bit about one site shall not be disproportionately responsible for the favorable effects seen applies in instances where there is only 1 study. That's what we have here.
    May 23 10:06 PM | Likes Like |Link to Comment
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