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Posted On: 11/03/2018 3:08:39 PM
Post# of 72446
Re: aragon1959 #50764
Thank you for clarifying both points.
Would you expect BTD would be granted if the FDA would approve based on the phase 2 results?
Do you feel the number of patients in our relatively small phase 2 for B-OM is enough? There were only about 30 treated and from there we had to choose the appropriate chemo treatment arm to show a strong benefit.
I'm having a hard time finding a phase 2 -> market FDA approval on 10-20 patients. Can you recall any off hand?
Thanks again.
Would you expect BTD would be granted if the FDA would approve based on the phase 2 results?
Do you feel the number of patients in our relatively small phase 2 for B-OM is enough? There were only about 30 treated and from there we had to choose the appropriate chemo treatment arm to show a strong benefit.
I'm having a hard time finding a phase 2 -> market FDA approval on 10-20 patients. Can you recall any off hand?
Thanks again.
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