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Re: bobbo379 post# 1307

Tuesday, 03/25/2014 10:17:52 AM

Tuesday, March 25, 2014 10:17:52 AM

Post# of 3353
bobbo - The process as you may, or may not, know is very involved and time consuming even with Orphan status and priority reviews it takes a fair bit. If the phases proceed they should provide a catalyst for data and eventually hopefully an NDA, and ADCOM and or PDFUA.

Some general FDA Phase time frames plusssss much else, for any who are interested.

http://www.patientnetwork.fda.gov/learn-how-drugs-devices-get-approved/drug-development-process/step-3-clinical-research?gclid=CMKztI7vrb0CFTMV7Aod11gAIA#phases

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