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Re: antihama post# 30859

Monday, 03/16/2015 10:26:52 PM

Monday, March 16, 2015 10:26:52 PM

Post# of 732922
We should all recall Northwest refute to AF, in particular the part about the recist criteria(below). Even if the majority of patients are seeing stable disease this is a very big deal and is considered a response using recist. Also keep in mind that this phase I is to assess safety primarily and we will easily meet this endpoint. There will be no failure to meet endpoints so the stock has absolutely no reason to tank as some here have suggested.

Actual facts: While still only part way through treatment, more than 50% of these patients (11 of the 19) have already shown tumor shrinkage of up to 28%, substantial tumor cell death and substantial accumulation of immune cells in the tumors. These data were shown in imaging scans and biopsies provided by the world-renowned cancer centers conducting this clinical trial, as the Company made clear in its announcement and conference call.

Feuerstein claim: “Under the globally accepted definition of tumor response known as RECIST (Response Evaluation Criteria in Solid Tumors), a partial response requires a 30% reduction in the size of the target lesion.”

Feuerstein claim: “DCVax-Direct: 0% response rate.”

Actual facts: There are numerous types of established measures of patient responses to treatments.

The measures reported in the Company’s announcement (partial tumor shrinkage, substantial tumor cell death and substantial accumulation of immune cells in the tumors) are considered clinically significant and are regularly the focus of peer reviewed scientific and medical publications in oncology, particularly for late stage disease which is the focus of the Company’s DCVax-Direct trial.

The RECIST criteria are just one set of measures, and the Company has made no claims about these measures. Further, the RECIST criteria themselves include multiple categories: they recognize not only a “Partial Response” of 30% or more — they also recognize “Stable Disease” (which includes tumor shrinkage of up to 28% as has been seen among the early responses in the Company’s DCVax-Direct trial).
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