Anyone who thinks that a 60 patient trial will be sufficient for the FDA regardless of the quality of the data is away with the fairies.
As far a credible reseach analyst pushing that view it just demonstrates that they infact have no credibility.
The company needs to come out in an announcement and disclose the trial(s) design, protocol and timetables clearly so that all of us can manage our own expectations.
to hotdat orphan drug ques for meeting on tues, page-3
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