@Shellbell, due to the seamless design for the CDH17 Phase 1/2 trial, we can transition into Phase 2 after the first 15 patients are dosed, without consultation with the FDA. The CEO is on record is saying she expects the company to be in phase 2, in the second half of this year. Which would be awesome!
but wait, it gets even better….
because CDH17 is a CART therapy, Phase 2 will likely be the pivotal / registrational trial for the FDA. That is, we don’t need to wait for the completion of phase 3 for marketing approval.
so, if the planets align, we literally will be leap frogging many of our ASX and international peers in a matter of months.
@Shellbell, due to the seamless design for the CDH17 Phase 1/2...
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