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Nice posts. The only point I would disagree on is that I don't...

  1. 494 Posts.
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    Nice posts. The only point I would disagree on is that I don't believe they would do an all comers trial. They have already established that for category 2 ulcers the treatment, while better than standard of care did not produce outstanding results. These ulcers would be treated by other more serious and expensive methods in a clinical setting. In regards to Margolis 0 patients, if it gets to the stage of reimbursements as a guess the trial data would automatically apply for Margolis 0 as well, it would be purely the case of how long patients need to not respond to standard of care before they would qualify for reimbursement. Margolis 1 is defined as greater than 5cm for less than six months, or those less than 5cm for more than six months. But in reality if a patient isn't responding to standard treatment after say one month then it may be possible that they may then be eligible as they could reasonably be predicted to fall into the middle category (without having to wait an additional 5months just to prove it)...
 
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