PISCES interim data was prematurely expected at ASCO.....simply too soon to present data there. Now 21 recruitment sites are enrolling patients for PISCES. We will most likely get interim data at SITC in November. Full enrollment is expected by 3rd quarter which means data will probably not be the full 23 patients in the first stage of the trial. Oncosec needs only a few patients to respond in the first stage of this simon minimax 2 stage trial to initiate the second stage of the trial with an additional 25 patients. When the first person was enrolled in December, Oncosec later gave the impression that the patient was having a positive response.....they were very excited about the trial start. If the interim data is good, then Oncosec will seek guidance from the FDA on fast-track approval. I think the idea is that they could initiate an early approval at the point they meet the 30% or greater threshold of responders....which would be a total of 16 patients out of 48. If they had outstanding results with 16 responders out of the first 23 patients in the first stage they would already have met the total responder numbers and could seek an early approval before stage 2 begins....that might be expecting pie in the sky though. Most likely it will take full enrollment of 48 patients and complete data next year for an approval by end of 2019.....commercialization in 2020.
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