Carol Potera responds:

If it appears that a positive tone was taken with some companies and not with others, it was unintentional. Not only the management at Isis, but also several of the other companies and academic antisense experts with whom I spoke expressed the common view that Genta has been treated very badly by the FDA. This was said with concern, not avarice. My comment “failure of the regulatory strategy” represents this common view. Perhaps it could have been strengthened with an added thought, such as “and does not reflect inferior science.”

My comment “missed the required statistical cutoff” was intended to reflect exactly what Stein mentions. Although there are other markers, such as partial nodular response, that show that Genasense is effective in certain patient populations, the FDA ignored them and only focused on overall survival.

As for LDH, in cutting a paragraph about Genasense in melanoma trials to shorten the article, the sentence about LDH was left in and combined with the preceding paragraph about CLL. This was a mistake I did not catch. As Stein says, LDH is a marker used in melanoma trials, not CLL.

As for the paper by O'Brien et al.1 that Stein mentions, that study was published in the March 20, 2007 issue of the Journal of Clinical Oncology, several months after I had submitted my original draft. I was not aware that this current study was available.