Sunday, November 13, 2016 9:16:54 PM
Apr '17 is an estimated start date for the pc trial that us longs have agreed upon, considering the Pre-IND meeting with the FDA has already been requested. KW didn't set the estimated start date - we did. DD shows it takes appx five months from the time the Pre-IND is requested to the start date of a trial. I intend to continue to buy until the pc trial begins.
Accumulating. Long. Go PMCB!
Page 4 demonstrates the timeline:
http://www.ucdmc.ucdavis.edu/clinicaltrials/training/documents/socra_bb_ind_marusina_2011.pdf
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
Accumulating. Long. Go PMCB!
Page 4 demonstrates the timeline:
http://www.ucdmc.ucdavis.edu/clinicaltrials/training/documents/socra_bb_ind_marusina_2011.pdf
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
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