Cel Sci Corporation (CVM)

[Duduza5]

FDA and additional trial

Squamous H/N tunors are staged after surgery by observing tissue specimen, nodal metastases and occasionally through PET/CT followed by biopsy of METS. Since all cancer therapies have to use SOC for ethical purposes, the pathway (chemo versus not) is set by the literature, the oncologist and the patient. The oncologist will typically recommend cisplatin (chemo) for higher risk tumors and the patient then decides whether to take chemo or not.

Fortunately these pathways are not built my CVM, which would be akine to throwing something against the wall to see if it sticks. Rather these pathways are built by longstanding journal research.

Long story short, CVM showed benefit in the subgroup you would expect to show benefit in with a result that is in line with other immunological therapy.

I do not believe you could ethically do a new-study with patients without chemo because >50% of recruited patients would not be eligible. Since the stratification of patients would occur after multikine and surgery, this would make for a poorly designed, wasteful and unreasonable study.

I believe all this means that Multikine gets either a thumbs up or thumbs down from the FDA, not a request for further studies. Since this subgroup of lower risk patients (14%) matched the Cisplatin improvement in higher risk patients (13%) then I think approval is more likely than not. I would not be surprised to see a study in the future where high risk patients are offered Multikine versus cisplatin but there are always ethical pitfalls to replacing SOC studies.

I would not be surprised for a phase 4 FDA request but a new phase 3 is unlikely IMHO.

Best!