14 Comments

    • Novartis Example: Why Drug Discovery / Development Is Hard [view article]
      Killerz,
      True, but no one predicted that a drug inducing lymphopenia would actually boost any part of the immune system before this study was done.

      The conclusion makes sense now, but I think it clearly illustrates how difficult biological systems are to predict, no?

      Eben
      Aug 15 09:46 AM
    • Wyeth and Elan Take Hits on Bad Trials [view article]
      Biotechbull,
      I don't totally disagree with your statement about evaluating programs based on NPV but you made one crucial error... why do you assume that all programs have a 67% success rate in phase III?

      Just because that is the industry average doesn't mean that it is the
      best number to use for bapineuzumab. You have to take other things into account: novel therapeutic target, missing phase II endpoints etc...

      Using 67% is mathematically lazy.

      Furthermore, your assumption that "all this drug has to do is not kill anyone" is completely off base. The FDA has been tighting like crazy, this is not the agency of four years ago when your comment would have made sense.

      Finally, given that:
      1.) the drug failed multiple endpoints (and no drug targeting any tau related protein has ever worked in the clinic)
      2.) has a pretty nasty dose-dependent AE of vasogenic edema
      3.) at best works in 30% of AD patients

      I'm all about disagreement but to hand wave using "average" statistics and make wildly off base judgment calls about the FDA approving anything that doesn't kill AD patients is not an argument that impresses me. Especially in the face of the three critical issues laid out above.

      Tesa,
      I'd totally agree that combination therapy holds the greatest promise.


      FrankieCooper
      For the record... I have never had a position in Wyeth or Elan. Though I now wish I had pulled the trigger on those shorts.

      Also, i fucked up the link in my blog... it's been fixed there and the link here:
      www.pharmababble.com/b.../



      Jul 31 07:20 AM
    • Wyeth and Elan Take Hits on Bad Trials [view article]
      Bozak,
      Thanks for reading. There is absolutely no connection between any adverse events seen with Tysabri vs Bapineuzumab. Two completely different mechanisms.

      Tysabri got in trouble because it does it's job too well. It suppresses the immune system by inhibiting a molecule (a4B1 integrin) used by immune cells to get into the brain. Exactly what you want if you have MS. Unfortunately, it did this job so well that an opportunistic virus, PML for short, showed up in a few patients (though none since the initial scare).

      So far, the most important adverse event for bapineuzumab has been vasogenic edema, or fluid buildup in the brain. This is really really not good, especially because the amount of fluid was dose dependently related to the amount of drug given.

      Anyway, two completely different problems. Hope that helps. I added some links if you want to know more.

      en.wikipedia.org/wiki/...
      en.wikipedia.org/wiki/...
      en.wikipedia.org/wiki/...
      Jul 30 01:03 PM
    • Kosan Acquired by Bristol-Myers for 233% Premium [view article]
      I've said it before... I'll say it again.... I can't edit this and I'm not the one adding the stock symbol information. I write on a personal blog (pharmababble.com) that seeking alpha syndicates. They add the ticker info.

      Seeking alpha messed up the symbol, not me.
      Jul 21 08:21 AM
    • Alzheimer Drug Fails Trial [view article]
      I think it's interesting that you all feel personal attacks are somehow a counter point.

      If, when the results are published in July and after the first phase III data is in, I am wrong, I'll be the first to admit it (I doubt you'll be offering me the same consideration and dropping me emails if I'm right).

      Until then, my opinion remains that no program targeting amyloid-beta or the pathway has shown efficacy on the primary (read: approvable) endpoint of ADAS-cog.

      I hope I'm wrong. I hope targeting the amyloid-beta pathway leads to truly disease modifying therapy but believing doesn't make it true.
      Jun 19 07:35 AM
    • Big Pharma in Effort to Stimulate Innovation [view article]
      DRich,
      I don't disagree that Pfizer shareholders don't have a valid gripe and that the company is floundering. I was speaking strictly from a revenue growth perspective. I don't think I made that clear in the post.

      Drug discovery and development is difficult (and recently it's been made only more so by the FDA), even for Pfizer.

      Expecting one or two blockbuster drugs a year is unreasonable. The low hanging fruit has been picked. It is just unreasonable to think that 50B in revenue can grow at 10%/yr given all the variables, but that is what people expect.

      Again, this doesn't mean that Pfizer doesn't need some managment changes or a rethinking of their strategic plan, just that we as investors should re-evaluate what we need out of pharma stocks.
      Jun 11 08:31 AM
    • Big Pharma in Effort to Stimulate Innovation [view article]
      The Real Expert,
      Where is your site? Where is your analysis? Are you just one of those losers who rips everyone else apart without bringing anything to the table?
      Jun 11 08:21 AM
    • What is GSK Thinking With Its Latest NDA? [view article]
      Rocc,
      Took me to school. Best comment ever. Period. Thanks for reading.
      Jun 02 09:39 PM
    • What is GSK Thinking With Its Latest NDA? [view article]
      Right... but I don't, nor does anyone outside the committee have access to the application. GKS and Ligand's stock dropped quite a bit on wednesday after the news. I wasn't the only one making assumptions.

      I was proffering opinion on comments by member of said committee and was asking anyone who has more regulatory experience than I, to comment and enlighten me.

      Waiting until the meeting has concluded and using their positive opinion still doesn't answer the question I asked. Do you have any insight to add or do you just chide those with an opinion?
      May 30 10:45 PM
    • What is GSK Thinking With Its Latest NDA? [view article]
      Right... but I don't, nor does anyone outside the committee have access to the application. GKS and Ligand's stock dropped quite a bit on wednesday after the news. I wasn't the only one making assumptions.

      I was proffering opinion on comments by member of said committee and was asking anyone who has more regulatory experience than I, to comment and enlighten me.

      Waiting until the meeting has concluded and using their positive opinion still doesn't answer the question I asked. Do you have any insight to add or do you just chide those with an opinion?
      May 30 10:45 PM
    • Icahn Steals The Future of Enzon Pharmaceuticals [view article]
      that's fair. May 08 11:02 AM
    • Icahn Steals The Future of Enzon Pharmaceuticals [view article]
      In addition, a company can be mainly valued by the NPV of it's future cash flows. I fail to see how spinning off the future revenue generators of the company (its discovery pipeline) is not devaluing. May 08 08:24 AM
    • Icahn Steals The Future of Enzon Pharmaceuticals [view article]
      ENZN opened at 9.85 and closed at 9.26.... how is that up? May 08 08:15 AM
    • Bristol-Myers Squibb To Be Acquired By…?? [view article]
      Yeah... not my fault. The editors of seeking alpha put the stock symbols in, I have no control over that. May 07 09:01 PM
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