Saturday, August 12, 2017 1:36:24 PM
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.
http://ir.pharmacytebiotech.com/all-sec-filings/content/0001019687-14-003803/0001019687-14-003803.pdf
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