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Aradigm Corporation Message Board

  • ndanger2 ndanger2 Aug 26, 2013 1:23 PM Flag

    You Go INSM!

    INSM pps is kicking butt! Everybody getting on board INSM. Great news for us ARDM longs. Future looking bright, NEED Ph 3 to start. Gotta believe one day ARDM will blow past INSM.

    Sentiment: Strong Buy

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    • Does anyone know what impact if anything the recent patent news by INSM has on or against ARDM. Does it block us in any way? thanks

      Sentiment: Strong Buy

    • why will it blow past insmed are they not fairly similar

      • 2 Replies to geterginto
      • This is not a "blow past" product, per se. It is probably safer because of the difference in safety between Cipro and amikacin. Also Cipro can be taken by mouth at the same time it is being inhaled. The biggest advantage for Pulmoquin and Arikace is that they are both once per day and it is unlikely, because of the uptake and retention of the liposome in macrophages, that the lung will be unprotected for more than just a few hours if a patient misses a dose. That is the biggest advantage. Also, I have heard testimonial (but not seen the data) that Pulmoquin has a greater log reduction of Pseudomonas aeruginosa bacteria than was observed with either Arikace or TOBI in various clinical trials. That is a factor that supports Pulmoquin immensely. But there does have to be a Phase III trial. The important news this last week was that Sigma-Tau will be the manufacturer. They have their own proprietary ophthalmic solution that they market which means they can meet cGMP criterial with the FDA. cGMP is certified Good Manufacturing Practice, which is the international standard for making drugs, biologicals and medical devices. So ARDM is making progress towards the Phase III clinical trial. I had forgotten to consider the need for a cGMP manufacturer for a Phase III clinical trial. The usual requirement for licensing is to have the manufacturer produce three different batches/lots of the product that meet the label copy specifications for purity and composition and have the Feds analyze thoses batches by the method chosen to demonstrate efficacy of the product.

        Sentiment: Strong Buy

      • Hi, thx for reading!

        Yes similar just in first 2 drugs. Hope ARDM blows past INSM someday because of other assets, pipeline, IP; smoking cessation huge potential to be realized maybe in 4 - 5 yrs.

        Sentiment: Strong Buy

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