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Regenerx Biopharmaceuticals Inc. Message Board

  • bocamp1 bocamp1 Jun 12, 2013 1:31 PM Flag

    Sno/Trial

    The real question on the EB trial is this; was the primary outcome met? The primary outcome was safety, not wound healing. If 1 AE and no SAE is good enough to merit safety, then trial was a success and primary outcome met. If that is the case, doesn't Sigma Tau have to come up with 5 million and finance the P3??

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    • bo.....I don't think that the EB trial will force ST to pony up $5 million. The wording is open ended, kind of. Here is exact from original announcement 2004:

      "When RegeneRx completes positive Phase II clinical trials in the United States, Defiante must either pay the Company $5 million or initiate pivotal Phase III clinical trials in Europe to maintain the license. "

      You can't force ST to pay $5 mill, IMO. why? Because in EB Phase 2, 8 of 22 (35%) were healed w/ TB 4. But in placebo 5 of 8 were healed (65%). The "numbers" say it was not a "successful" trial. The placebo group got 65% cure rate. The TB 4 group got 35%. So how can RGRX force ST to pay $5 million? Doesn't matter about safety and sides.

      if this was an OPEN LABEL trial w/ no placebo, the EB trial was a huge success! Shire Pharma was okayed by the FDA to do a PHASE 3 trial in EB, w/ only 20 pts and OPEN LABEL NO PLACEBO...for approval. Something happened in TB 4 EB trial. EB patients and parents are DESPERATE for ANY drug therapy, because there IS NONE. Placebo water gels won't heal ED blisters! So what happend in our Phs 2??? If RGRX asks FDA to REMOVE from consideration the placebo comparator, and only focus on number of patients "healed"? I believe the FDA might approve TB 4 soley on this Phs 2. EB suffers are that desperate. RGRX started this trial in 2006. thera are NO patients for more trials! SHIRE can only get a 20 pt phs 3. It took RGRX from 2006 to 2013!

    • Might be cheaper for Sigma Tau to just buy up the company (31 million shares at 7 or 8 cents, and they already control 49%) They would only need to spend $3.16 million if they paid as much as 20 cents a share for the 51% they don't already control.

      Sentiment: Hold

 
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