I think that the most important question to ask is:
"How many patients do you expect will be involved in the Phase IIb / III trial, and do you expect that this will be the only trial that is required for US FDA registration?"
The company has allowed groups like Alpha Securities and one of the biotech newsletters to run with the "60 patient" figure - but I think that we need to hear it straight from the horse's mouth.
to hotdat orphan drug ques for meeting on tues, page-2
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