Biotech Values

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<But I have to say that it tends to back up my claim that Provenge is a rather weak immunostimulant given that only 38 patients met this criteria. Imagine what the overall survival survival data would look like if 76 met the criteria, for example?>

Note that the PR yesterday mentioned that the new analysis treated CD54 upregulation as a continuous variable. The p-value given was .011 which was likely much larger than that from the Provost chart comparing the populations above and below median. The important part is that the new analysis says that there is a clear correlation in the level of upregulation to survival.

At what upregulation level that potency is achieved is still not yet published - at least not where we can see it. But if you read the transcript of the FDA workshop where the early data were presented, Dr. Provost mentioned that there were cases when the product did not meet their threshold so they asked the patients to come in again and the results were fine second time. This says that CD54 upregulation is not always a persistent characteristic of the patient like a gene or some such that you can use to say if a particular patient would or would not benefit from the drug. It is mostly just a potency measure of the product at the time it is made.