% | $
Quotes you view appear here for quick access.

Coronado Biosciences, Inc. Message Board

  • trigfest99 trigfest99 Sep 23, 2013 11:58 AM Flag

    Recent Thoughts

    Regarding differences bw TRUST 1 and TRUST 2:...a couple of things I had picked up recently. First, from last CNDO CC, CEO said that Trust 2 (Europe) inclusion criteria prohibited any Crohn's drugs at all. Trust 1 did allow certain drugs (but i believe both excluded TNF inhibitors). Second, from bioinvest recent issue, I learned that Trust 2 did not do a colonoscopy to test for active Crohn's. Conversely, Trust 1(USA trial) did do a colonoscopy and was very careful to include only patients that they were very confident had active Crohn's.
    I am looking for signs that Trust 1 has more likelihood of success than Trust 2 (i personally believe Trust 2, if successful, will achieve statistical significance by a relatively narrow margin).
    Conclusion re fact 1: I don't know (anybody?)
    Conclusion re fact 2: It is obviously harder to achieve a statistically significant improvement if you are perhaps measuring people that don't even have active Crohn's. So this is a positive in terms of chances of a favorable or overwhelmingly favorable Trust-1 result, which seems less likely for Trust-2.(IMO).

    OTHER STUFF: I also had noticed in the past, but never seen any comment on, that the starting upper range of the CDAI of the patients is 100 points higher for Trust-1 than Trust-2. This is a positive in terms of design as it relates to primary endpoints. (Trust 1 PE is positive response 100, Trust 2 PE is remission= 100 for positive response if high range CDAI is 550 since for those upper patients 100 is a lower percentage of the starting CDAI. Also, for Trust-2 it is easier to get to

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • There is a chance that TRUST-1 p

    • "Second, from bioinvest recent issue, I learned that Trust 2 did not do a colonoscopy to test for active Crohn's. Conversely, Trust 1(USA trial) did do a colonoscopy..."

      I looked up both trials on clinicaltrialsdotgov and both listed the following identical entry criteria "Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria" As long as the prior experiences are not statistical flukes or corrupted by some kind of unfortunate bias, I am hopeful both trials con show very positive results. We'll see soon enough.

      • 1 Reply to ehw1952
      • here's the newsletter quote: "Dr. Falk almost reached statistical significance in April 2012 with Trust-ll (their TSO study that will take a second interim look shortly after CNDO's) without performing colonoscopies." These guys are usually pretty accurate. You can reconcile the info on the FDA site with the patients having previously done colonoscopies, without Falk actually having done them in the screening. Alternatively, one or the other is inaccurate.

    • As I mentioned before, CNDO's biggest issue is Dr. Falker. Those europeans not only piggyback us, but also make things complex. We should issue some shares next year to buy them out.

    • wow Y mangled what I said in "other stuff". oh well...

4.110.0000(0.00%)Apr 23 3:59 PMEDT