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.
3