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jq1234

04/17/14 12:21 AM

#176932 RE: pcrutch #176930

I am not saying SRPT did everything right at all. There are many aspects they could improve. They communicated too much last year IMO, especially detail of one particular trial design but not others under consideration.

I don't think they'll consider to provide expanded access until they finalize ph3 design, know the size and duration of trial needed. Currently they probably only have mid scale manufacture ready, not the large scale.

Most companies don't provide exact date of FDA meeting. Trial design can't be finalized via one meeting alone, it is a back and forth process. They probably learned their lessons, don't say anything until there is resolution.