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DewDiligence

06/24/13 6:00 PM

#163004 RE: DewDiligence #162969

I was planning to make the PTLA discussion in #msg-89306565 a quiz. Would anyone have gotten the answer?
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pistol1p

06/24/13 7:13 PM

#163013 RE: DewDiligence #162969

The FDA label for Lovenox, to treat VTE, was derived from clinical trials and thus the indication to treat and the duration of treatment is based on statistically significant outcomes of those trials.

What would cause the current Betrixaban clinical trial to be worthless, would be for PTLA to use a non-FDA approved treatment protocol for Lovenox because that protocol would not have been proven effective in a clinical trial.

The goal of this clinical trial is to show that Betrixaban is as effective or more effective than Lovenox at its' proven effective dosing regime.
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DewDiligence

08/07/13 4:13 PM

#165043 RE: DewDiligence #162969

PTLA’s CMO is resigning for no stated reason:

http://www.sec.gov/Archives/edgar/data/1269021/000119312513324147/d581077d8k.htm

Perhaps the reason is lack of confidence in the phase-3 program for Betrixaban (#msg-89306565).