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Monday, October 12, 2020 11:27:19 AM
(SEC)
In our prior comment 3,
Concerning the small number of patients treated in the Phase 1/2 trial, we referred to response #7 from your August 15, 2014 letter. In that response, you included proposed disclosure which began: In the Phase1/2 trial only a small number of patients were evaluable. As a result, statistical parameters were not used in the published reports of the Phase 1/2 trial to validate the anticancer efficacy of the Cell-in-aBox/low-dose ifosfamide combination in patients with advanced, inoperable pancreatic cancer…
Please delete the sentence from your proposed disclosure that states “It is unlikely, even with the small number of patients…that the increases in median survival time and percentage of one-year survivors …were due to chance alone….” This is a statement of opinion that purports to be factual in nature and is, therefore, inappropriate. Since statistical significance could not be measured in this trial, you cannot exclude the possibility that the results were due to chance. Therefore, please replace the sentence quoted above with a statement explaining that because the results were not statistically significant, any observations of efficacy must be weighed against the possibility that the results were due to chance alone.
https://ir.pharmacyte.com/all-sec-filings/content/0001019687-14-003803/0001019687-14-003803.pdf
https://ir.pharmacyte.com/all-sec-filings?form_type=CORRESP
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