Wednesday, April 27, 2016 10:02:49 AM
the Pre-IND is not done until the facility is GMP...the facility information is put in the CMC part of the IND...
the IND application material is given to the FDA and the Pre-IND is usually done over the phone...if all is in order the application will be submitted for approval to start the trial...if no answer within 30 days...we start enrollment...
what takes a little time is getting the Pre-IND meeting...BUT...keep in mind with Von Hoff involved that time could be drastically shortened...just like our Orphan Drug Designation was...
bull
Recent PMCB News
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