I would say at this point they have everything they need to meet with the FDA. It's the scheduling part they are waiting for now. They have only been GMP compliant for a couple days. They could not request their pre-IND meeting until that was done.
Everything left before the PC Trial... can be done and the start date be on time...they don't just sit back and wait for one thing at a time to be completed...I am sure there are many things going on at once...
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...
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