Ann: IMUGENE DOSES FIRST PATIENT IN VAXINIA PHASE 1 TRIAL, page-62

Yes, that is the requirement of PH1 trial to ensure safety and toxicity is met. But, it does not prevent the investigator from having a peek to see if it is effective as well. Especially when you get patients coming in with bent back and bent knees to doing cartwheel in front of you Just like in the first cohort of patients in that PD1-Vaxx trial which was also meant to ensure safety and efficacy first. But then, they have a patient who could now do cartwheel for more than a year on with not a sign of the cancer in the patient's body.

The difference now of course is that this is a trial on solid tumors. No treatment currently available. Any positive sign, and FDA could well fast track this baby into the world, especially once safety and tolerability is proven.