Pete - They'll give us the trial outline soon. It
Post# of 72447
Posted On: 09/28/2013 2:08:12 PM
Pete - They'll give us the trial outline soon. It will likely be multi-arm, lowest dose, working with refining time frame for response across range of conditions. Treatment time indicated for mrsa filled wound of moderate severity may be different from mrsa pneumonia. This study will help establish those timelines and hopefully show continued good safety data that earlier low dose studies showed. They could do this trial very quickly if all went well - 6 months start to finish is possible - it is much easier medicine to work with than a cancer agent. If they want rapid path - they will make this study large, include a few hundred people (600 would be my minimal goal to lay foundation work to eliminate hypertensive signaling), double-blind it, etc..
Your last paragraph basically says you want the K phI to turn into combined phI/II study. They would have had to design it that way from the beginning and obtained approval from FDA for that design. The combined phI/II is done often and becoming more common in this age of nontoxic novel molecules - but CTIX didn't choose that model - perhaps because they have others stepping in to do some of that more mature trial work for them.
Your last paragraph basically says you want the K phI to turn into combined phI/II study. They would have had to design it that way from the beginning and obtained approval from FDA for that design. The combined phI/II is done often and becoming more common in this age of nontoxic novel molecules - but CTIX didn't choose that model - perhaps because they have others stepping in to do some of that more mature trial work for them.
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