Assuming all goes as planned, patients that have been

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MJS719 HouseofCards #159097
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Assuming all goes as planned, patients that have been diagnosed with "disease progression" in our CRC trial will be able to enter the rollover protocol and get 700mg of Leronlimab and an ICI. Patients who are determined to be stable at week 48 will be able to continue to receive Leronlimab. So if after 20 weeks it is determined that a patients cancer is progressing, then they will be able to exit the current trial and enter the rollover protocol portion of the trial. The patient does not need to wait 48 weeks to go the rollover protocol. They simply need to show disease progression. The length of stable disease and disease progression will still be used for the original trial calculations and the patient will still be able to get the necessary 700mg of Leronlimab and the ICI. So whether they get 350 or 700 at the onset should not prevent them from eventually getting the Leronlimab and ICI. At least that is how I interpret what was put out in September: With that in mind, we have prepared a rollover protocol to ensure that CRC patients who remain stable can continue leronlimab treatment beyond 48 weeks and to allow patients with disease progression the opportunity to receive leronlimab at a dose of 700 mg in combination with an ICI.

And if the FDA does not approve this, then the patient with disease progression and proven "cold to hot" tumor environment can withdraw from the trial and get an ICI on their own (worse case situation). I think everything is going to work out okay no matter what the FDA does.

We can't force a patient to continue to go down a path that results in death especially if we know there is another path they can take.

I am very confident our CEO is on top of this and is doing everything possible to get the rollover protocol we need.

There is so much new data on this "cold to hot" out there that oncologist will give their patients an ICI should they diagnosed as disease progressing but also have a hot tumor environment for an ICI.

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