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Transition Therapeutics Inc. Message Board

chargerfanus2003 2 posts  |  Last Activity: Jun 12, 2015 11:04 AM Member since: Oct 22, 2003
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  • chargerfanus2003 by chargerfanus2003 Jun 12, 2015 11:04 AM Flag

    the agreement with Jannsen calls for up to 900M in various payments.
    A phase 2 trial is expected to be started mid 2015 (now!) and typically that would call for a milestone payment.
    How much? We won't know until it happens. The orphan drug designation will allow the drug to be sold at a higher cost when/if approved so that makes it more appealing to Janssen/JNJ to get this moving through the trials.

    We should expect a press release very soon announcing start of a P2 trial and milestone payment to GERN

  • Reply to

    If JNJ Applied For Orphan Status

    by mruyog Jun 12, 2015 10:39 AM
    chargerfanus2003 chargerfanus2003 Jun 12, 2015 10:47 AM Flag

    from FDA site, "Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request."

    So you can see FDA does not just grant status because it is requested, it is EARNED. That is why this matters, in Nov 2011 Jakafi was approved for use for myelofibrosis. In order for JNJ to get this orphan status approved the data had to support approval.
    imet data had to be good enough to impress FDA. Most likely the data looks as good or better than jakafi.

    This is a BFD
    And yes I have added shares this am.

TTHI
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