Cel Sci Corporation (CVM)

[Dr. Johnny Fever]

"What if the trial had worked in high risk only? In men? I those with stage 1? In US patients? In those over 65?"

Interesting points you make here. If the trial had worked only in high-risk patients, this would have been fantastic news, since that represents a larger group of patients than the low-risk group. If the trial results had shown that only men benefitted (or women, for that matter), then something interesting would have been found, but probably not something that could have been submitted to the FDA, since these results were not tested for in the trial's design. As for stage I patients, there were no stage I patients in the trial, only stage III and stage IV patients. If the trial had shown success only in the U.S., then the trial would have failed, because U.S. patient exclusivity wasn't designated in the trial's design. Similarly, age groups weren't specified in the trial's design.

"There are plenty of ways to do this. But they must defined in advance."

Per the 07/07/21 Letter to Shareholders:
"The analysis for the successful treatment arm was pre-specified in the study protocol and also the study Statistical Analysis Plan (SAP). These documents specified that we would analyze and present to the FDA not only the combined results of the two treatment arms but also each individual treatment arm, such as Multikine followed by surgery and radiation (the successful group in the study) and also Multikine followed by surgery and radiochemotherapy. What we saw in the study is that patients who had been treated with Multikine followed by surgery and radiation had a robust and durable survival benefit that exceeded the parameters set for the study endpoints, but we also saw that when chemotherapy was added to radiation in the other treatment group, the survival benefit from Multikine was negated."

CVM can submit the data for the low-risk group to the FDA and seek approval. I am of the opinion that they will get it. Why wouldn't they? What is there to lose? It's non-toxic, and as it's a neoadjuvant, it doesn't change SOC in any way if it doesn't work for any particular patient.