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Re: attilathehunt post# 26802

Monday, 06/24/2019 11:53:33 PM

Monday, June 24, 2019 11:53:33 PM

Post# of 34625
Not necessarily. Conditional approval would have to fall on a phase 2 study.

For instance the post-transplant AML study using MultiTAA is a phase 1/2 study. The phase 2 study for post-transplant AML is set to begin Q3 2019. If that data ends up meeting endpoint that would e conditional approval for post-transplant AML.

The pancreatic cancer study is a phase 1/2 study. That means Marker will need to run a phase 2 study with a small group of patients probably 20 or 30 patients. Then if that study meets the primary endpoint, it's possible accelerated approval can be given.

I never seen an instance where the FDA allows for accelerated approval after a phase 1/2 study.
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