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ImmunoGen, Inc. Message Board

lieinhart 5 posts  |  Last Activity: Oct 8, 2014 12:09 PM Member since: Dec 1, 2008
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  • lieinhart by lieinhart Oct 8, 2014 12:09 PM Flag

    I thought that during phase one studies they kept raising the dose to maximum tolerated dose and then used that dose in phase two. This apparently didn't happen. Any thoughts?

  • Reply to

    Gutless FDA

    by lieinhart Aug 27, 2014 1:18 PM
    lieinhart lieinhart Aug 27, 2014 1:54 PM Flag

    Only patients with subacute injuries can receive this treatment. Over time the injured cord develops cavities, which expand with more time. Scar formation also occurs, both of which,make recovery impossible. So patients with previous incomplete cord injuries and those injured in the foreseeable future will never be able to receive this treatment. That's why during Geron's trial, patients with recent incomplete injuries and their families were begging to enter the trial, willing to undertake any risk.

  • lieinhart by lieinhart Aug 27, 2014 1:18 PM Flag

    The gutless FDA has done the same thing they did to Geron, causing Geron to drop its stem cell program.. The treatment worked only in rats with incomplete spinal cord injuries, not complete injuries. The FDA made them run its trial with complete injuries, because these patients had less to lose if there were safety problems. For the same reason, it made them use thoracic cord injuries, which are now extremely rare (air bag use), not cervical spine injuries. Now that safety has been established, the FDA should allow trial with partial cervical spine injuries. It will probably be a decade before patients with incomplete cord injuries have this Rx available to them. It won't work on complete injuries.

  • Reply to

    C.Dif News reported today!

    by parabalic55 Aug 5, 2014 1:24 PM
    lieinhart lieinhart Aug 5, 2014 6:06 PM Flag

    The only thumbs down I see are for my request for a reference or link to INO, which so far has not appeared. Unbelievable.

  • Reply to

    C.Dif News reported today!

    by parabalic55 Aug 5, 2014 1:24 PM
    lieinhart lieinhart Aug 5, 2014 2:10 PM Flag

    INO has not issued any announcement. The article, from July 31, mentions Drexel University but not Penn. Do you have a reference or link for the INO connection?

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