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Insmed Incorporated Message Board

  • insm_truth_teller insm_truth_teller Dec 25, 2012 7:02 AM Flag

    Reported to Yahoo! ALL THE SAME PERSON ADD blanktothisone stu_har b_leaguered fudfighter4 bohemianclubman


    Reported to Yahoo! ALL THE SAME PERSON ADD blanktothisone stu_har b_leaguered fudfighter4 bohemianclubman

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    • The last time it took about 6 or 7 months for the data and the decision from the FDA to lift the clinical hold on the additional data presented.Is there a timeline for the FDA once they get the dog trial data?
      Will the EU CF data be released before the FDA decision on the dog trial?

    • Reported to Yahoo! ALL THE SAME PERSON ADD blanktothisone stu_har b_leaguered fudfighter4 bohemianclubman

    • What rock did you crawl out from under? DA!

    • rehdvm2004.Dec 12, 2012 4:14 PM.
      "There will be no partners or brokerages following until after the dog trial. If it is not completely favorable to the FDA, Insmed is toast."

      The dog trial (which is a repeat preclinical study, BTW) has a 99% chance of showing nothing precancerous. The Foamy Macrophages (damaged cell type leaked by a Wedbrush statement) is a precancerous lesion if it occurs from an unknown cause. There is intracell lipid and an increase in mitotic figures (cell division of the nucleus). But this lesion also occurs following a natural build-up of the lipids. One of the most common causes for this finding (post mortem) was women who used a lot of hairspray. But it also occurs when Arikace (lipid and amikacin) is engulfed, taken-in, absorbed by the fixed macrophages (FMs) in the lung. The same phenomenon that Spumpers point out makes the antibiotic effective against NTM as well as TB (a fudspec) inside the macrophage causes a benign, concurrent build-up of thelipid in the FM. The FM has to get rid of the lipid after the bacteria are killed by the amikacin. The bacteria are dead in a few hours, but the lipid has to be digested by the macrophage and "spit out" into the musous flowing out of the lungs, OR the bloodstream. It does not go back out of the lung by aerosol, the way it came into the lung. While dog lung studies are not common, the ones that have shown carcinogenic potential have been inhaled smoke form cigaretts, inhaled radioactive particles and inhaled benzene ring compounds. These can all be found online by a scientific literature search. But the point is, the Arikace lipid is not carcinogenic. A few Sudan Black and Sudan Red stained lung sections will prove this out (special stains for lipids) along with a close look at the cell division sections of the FMs. No toxicity there.

      But the most importang single phrase that was uttered by the presenter was "NTM is our market." This confirms what I am hoping that INSM will stay focused on the brass ring.

      We shall see.

      • 1 Reply to insm_truth_teller
      • By satltsasw.Nov 20, 2012 1:07 PM.

        1. Zero sales...the regulatory path between here and commercial sales is longer than a year. No regulatory approval, no sales.
        2. Large mfring facility...regardless of "access" Insmed must still qualify the manufacturing of a new product line. This would involved a fully staffed QA/QC operation at both Insmed and the manufacturing facility that would address the manufacturing of Arikace. Not a previously manufactured drug.
        3. Zero sales force. No drug, no sales force. No competent company hires in advance of readiness to actually sell the drug. Further, the sales staff must have complete printed materials on the drug with attendant disclaimers etc. The legal time to codge that together is months. Graphic design, packaging etc takes several weeks to complete. And that cannot be completed until the legal language and IFUs are completed.
        4. Zero infrastructure. The infrastructure needed to run a company in the steps from R&D to startup to pilot manufacturing to large scale manufacturing, with attendant QA and regulatory is enormous. I'm not sure what your background is, but you do not understand infrastructure. Engineering, sales, chemistry, R&D, regulatory, inside/outside sales, marketing, legal, IT, production, packaging, never ending inside and outside audits, procurement and logistics, real estate and space management, contracts and legal, finance.
        5. Yes...I venture to say that Insmed will have zero of these.

        And, the pre-emptive name calling of "windbag" .... your response is complete.

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