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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Dec 3, 2012 10:08 AM Flag

    FaceTheFacts INSM Longs - Finally!

    Hats off to Lewis and the new direction for INSM.

    The revised Investor Presentation is packed with clearer scientific concepts, verifies the CF/Pa clinical sites in Europe and Canada, provides information on manufacturing at a cGMP contract facility and suggests (that word has to be emphasized until the NTM data is in) that the FDA will allow both an expedited path to an NDA for Arikace and compassionate use for NTM. The protocol for compassionate use will probably set aside the 6 months precondition for currently approved systemic NTM treatment and the criteria for "no change in therapy at least 28 days prior" to beginning Arikace therapy. I hope that some form of preliminary data for NTM will appear in an abstract out of NIH in the next 3-6 months. That would cement the future. People who scan Medline should look for something to appear along those lines after February. The findings will probably be eradication (hopefully within 30 days) and or two log reduction in the same time period. The current Phase IIb protocol is for 84 day eradication and time to exacerbation. The interesting part will be as to what types of concurrent therapy will the FDA allow while Arikace is being used. If they allow systemic antibiotics at the same time as Arikace, the NTM bacteria would be trapped in a "vice" of secretions with antibiotic and inhaled liposomes with antibiotic. The "deadly bacteria vice therapy."

    Again this presentation is missing only the final proof that Arikace will be expedited to approval. But mid-2013 is not that long to waite for the NTM data. This presentation is a big event in INSM's struggle for credibility and effort to get a product launched.

    Upgrade to . . .

    Sentiment: Buy

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    • Wedbush :
      Even the clown car should have seen Wedbushs last 2 calls were not for them but traders

      Anyone that thinks Insmed has "billion dollar potential" and yet is not being following by Wall street may want to ask why not.

      I hold a bio that hopes to do just that - a billion dollars, and the number of analyts following ? .......13
      Good Luck

    • price up sentiment up risk up

    • I forgot about the inhalation dog study that will be critical to filing an NDA for either use (NTM or CF/Pa). That study will have to be reported to the FDA when INSM asks for expedited review, or files an NDA at the end of a study. Looking for that first report about NTM. I think the Phase III CF/Pa will show equivalency for antibiotic kill, but maybe a bit better FEV1. We shall see.

      Sentiment: Buy

    • There will need to be more data before anyone lets anything become a compassionate care drug

      • 2 Replies to rosemariecorbin
      • A "compassionate use" is predicated on "a level of safety that produces no greater risk to the patient than the disease itself." Compassionate INDs are done all the time in IRB approved cancer trials such as Dana Farber. "Compassionate INDs" are approved by the IRB of one institution and cannot be "exported" over a state line. That would constitute "commerce" ane would require a drug approval. A "compassionate IND" approved by the FDA (similar to the EAP plan for Iplex) can go over a state line provided each institution that wants to use the drug compassionately follow the same protocol and get the protocol approved by their IRB. That is why a specific protocol is filed with the FDA. If it is an approved drug, not IRB protocol is needed, physicians just prescribe the use of the drug. That is the difference.

        As for early approval, that can occur if the treatment outcomes are better than the 84 day maximum treatment period in the Phase IIb protocol.

        I, personally, am hopeful that the 7 year wait has a chance once again.

        Sentiment: Buy

      • Rosemariecorbin - You don't know much about compassionate use programs, do you?

    • Re your -

      "... and suggests (that word has to be emphasized until the NTM data is in) that the FDA will allow both an expedited path to an NDA for Arikace and compassionate use for NTM."

      - you misunderstand.

      The preliminary NTM data is not due until the end of next year. The proposed launch of the Compassionate Use program is clearly not dependent upon that preliminary data.

    • perhaps those that dont trade or invest in bios may want to ask why Wall street (except wb) is not following Insmed.

      I am currently owning and following a company that hopes one day to do just that one day - a billion dollars!

      The number of analysts there ? ..................13
      Good Luck

    • perhaps those that dont trade or invest in bios may want to ask why Wall street (except the stoolie Wedbush) is not following Insmed.

      I am currently owning and following a company that hopes one day to do just that one day - a billion dollars!

      The number of analysts there ? ..................13
      Good Luck

    • perhaps those that dont trade or invest in bios may want to ask why Wall street (except wb) is not following Insmed. I know ...its a big secret but
      I am currently owning and following a company that hopes one day to do just that one day - a billion dollars!

      The number of analysts there ? ..................13
      Good Luck

    • Wedbush :
      Even the clown car should have seen Wedbushs last 2 calls were not for them but for those in the betting parlor( $15!! right before the Clinical hold etc)

      Anyone that thinks Insmed has "billion dollar potential" and yet is not being following by Wall street may want to ask why not.
      I hold a bio that hopes to do just that - a billion dollars, and the number of analyts following ? .......13

 
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