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Re: north40000 post# 29396

Thursday, 02/10/2011 4:55:54 PM

Thursday, February 10, 2011 4:55:54 PM

Post# of 92948
north,


point well taken as I should have started that statement with the word MOST...you can also find some IRB's that are done in weeks but in both cases neither are the norm from what I have found when searching the IRB times at many different institutions. Caldwell said the following prior to IND filing, "Typically, that process takes 60-90 days depending on the institution’s internal protocol approval requirements". I have found that to be more of the normal average in MOST cases. The fact the SMD occurs in juveniles and children may be used in trials sets off another level of protocol also. The fact that ACT stated on their website IRB approved protocol, begin in first quarter and a January 3 PR stating data would be on clinicaltrials.gov "shortly" tells me they were pretty confident in moving forward at that time and something happened that changed all that....thanks

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