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Insmed Incorporated Message Board

  • bohemianclubman bohemianclubman Mar 14, 2012 7:33 AM Flag

    Insmed Conference Call

    After being on over a dozen consecutive calls, this one, IMO, was the most revealing. Whitten apparently said the heck with all of that proprietary stuff about the rat study, and described the study in detail. 120 rats, dosed at super high levels for two straight years, and two rats developed a single tumor.

    Insmed took over thirty days to respond to the FDA regarding their strong scientific rationale regarding the study results. Of course rummdum says that if they would have just consulted a veterinary pathologist, it would have been no problem. Darn, why didn't Insmed think of that???

    Rummdum also believes that the company should focus on NTM and have some iPLEX manufactured while forgetting about CF for now. Wait a minute... the European medicines agency is letting Insmed proceed with the CF trial vs. the current standard of care - TOBI, in what could turn out to be a type of "winner take all" trial. It seems as though the EMEA has said the heck with all of that harmonization stuff, two sick rats is not enough for us to stop CF victims from possibly getting a more effective treatment option!

    Of course, the FDA is letting Insmed proceed with the NTM trial..... does that mean the FDA has determined that NTM sufferers are worth whatever risk the FDA has decided arikace presents, but CF victims are not?? The trial, however, is a phase II rather than the previously filed phase III - which the FDA had asked for!! When questioned why, Whitten basically said that he does not have a clue! The trial design is identical.

    Anyway, the questionably delayed arikace trials appear about ready to get started, and if those "phase II results which generally translate into positive phase III results" prove out, Insmed should begin to garner a little more attention than it has in recent months.

    Oh yeah, although not discussed on the call, Accugrowth was quick to point out that an additional three babies have been dosed in Sweden. If the original five that were dosed well over a year ago were not showing any positive results, would Premacure have begun dosing again??

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