KW said a third trial re-design is in order. Last time they changed the trail design it took months. That must be done before IND package is submitted. After that FDA has 30 days to respond. I personally think PMCB will be fortunate to get in the clinic this calendar year.
He basically laid out the trial design for us on the call... they have everything they need except their decision as to what drug to run in the control arm...
Any other redesign was related to imaging endpoint frequency of imaging and patients # needed.... this is simple stuff... and the FDA gave them all the info they needed
My question was (regarding a fellow shareholder statement earlier) why didn't we announced the "pivotal" or possible pivotal state upgrade right after meeting with FDA? Why wait for mainstream media after meeting with shareholders?
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