As Bundy pointed out, biggest changes are: Shifting from Ph1/2a...

As Bundy pointed out, biggest changes are:

• Shifting from Ph1/2a to a Ph1/1b making it a dose expansion vs. dose escalation and moving from a single ascending dose (SAD, Ph1a) to a multiple ascending dose (MAD, Ph1b) allowing for faster, parallel expansion. For example, instead of waiting for a whole cohort to enroll, sponsors will sometimes employ a 3+3 study where they can dose 3 subjects in a cohort, review safety data, and then escalate to another dose and do the same.
• Addition of another dose level (4c) which is now double the previous dose (1000e6 vs. 500e6) and done as 2 administrations, day 0 and day 5
• Updates to key exclusion criteria
• Addition of a few clinical sites in the US (one at the U of Maryland where I live!) and updates of a few to enrollment complete

The shift to further dose escalation marks they haven't found their clinically viable dose / maximum tolerated dose before seeing safety issues so still have room to see expanded efficacy. Good, but all equals more time in the clinic...

Long time IMU HC reader and investor, first time poster! Cheers from the States!