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Regenerx Biopharmaceuticals Inc. Message Board

  • snogreen snogreen Mar 24, 2013 11:34 AM Flag

    Odd things, with EB and FDA

    Humm. Some odd stuff popped up on clinicaltrialsdotgov. On feb 6 1013, RGRX did an updatyed filing with teh FDA. It seems that they have re-worded teh trial protocl somewhat. Go look. And they added in the FDA Office for Orphan Drugs on it now too. They before described it as a Phase 2 for safety and tolerability. Now the protocol ONLY looks for pts with "serious and adverse" effects. Then they switched the efficacy end. They changed that language to "those whose lesions have healed". This is weird. It reads to me like the FDA blesed changing trial to show if ONLY ANY serious adverse effects. Don't think there are any. BUT? then FDA changes from a STATISTICAL REVIEW of "efficacy" to ONLY number of pts who HEALED. This could be important? Think this. what if there are NO adverse effects anywhere. But what if statitically, the 30 pts didn't reach 'staistical" threshold. BUT? what if a few patients WERE healed with TB 4? The FDA wouldn't approve it because these few that were healed weren't "statistical" but the FDA Allowed the CHANGE in protocol OFF statistical, and now only number of pts "healed". Why woudl teh FDA not allow TB 4, if there are no sides and it does work for a few? Go read it and see what you all think? I think it could be GOOD!

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    • any updates?

      • 1 Reply to svvsone
      • No updates on EB from mgmt. All we know is what is on clinicaltrials site. RGRX gave FDA the results 8 of 22 in trial on TB 4 showed complete healing of EB blisters. we don't knwo how many others had a "partial" healing..there was no measure of that in protocol...endpoint was complete closure of blister. However, the site also showed that 5 of 8 on "placebo water type gel" also had healing. That is a problem for trial explanation to FDA. There is no drug, no real treatment, for severe EB blisters. So in theory it is impossible to get a healed response - off a placebo water gel...unless the gel was changed to TB 4. On the face of it, the EB trial was a complete winner for healing. But the placebo response wil create an issue with FDA. we need explanation. but RGRX silent.

 
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