Wrote this in Sweden today. As always, excuse for the quick Google translate solution:
"We do not know the absolute figures for how many people have received 30% respectively 50% pain relief after six weeks of treatment in the last cancer pain trial. We have though the results from the two 4 weeks of treatment studies.
We do not know when NP-1 will stop giving the patient no more pain relief after each added therapy weeks. We do not know the slope of the curve.
The placebo effect is a subject in itself among statisticians, and even more so when looking at the perceived pain. Here we study the same diagnosis, but with different cause (PHN, cancer or diabetes) that have given injured and trapped nerve which causes pain.
As a statistician, you should always be humble in that each placebo effect is unique. Having said that management can already do a multivariate / meta-analysis of all the three surveys to check this.
At the margin, it is all about if the placebo effect between the three surveys of the same disease would vary so strongly that the effect of each new week would only apply to neuropathic pain in cancer patients, but not, for example, in diabetic neuropathic pain. Company management can analys the data from the two previous trials to see if such an increase in effect for each week were there too. They may also perform a multivariat / meta analysis. Of course they already know the answer to the question: Do the result build up over time, after each added week, in the two first trials as well as in the cancer pain study? Talley stated on the last webcast that NP-1 have had a "breakthrough" concerning efficacy given the results in the last trial.
Neuropathic pain of cancer is about 2 million patients in the United States. Neuropathic pain in the general diagnosis includingdiabetes pain has 15 million patients. The latter broad diagnosis have 12 weeks in the FDA guidance for the design of phase III-trials. One approach that seems to fit the NP-1 cream very good?"
- Please, be precise about diagnosis. This is neuropathic pain. There are no, zerro, approved drugs for pain in cancer.
Why do you think NCI bother, for fun?
There is a cream with less efficacy than NP-1 have shown until now, that works through heat. Side effects. PHN diagnosis, if I remember correct.
But that was not the answer you wanted?
Management awaits the publishing of the data in the abstracts to ASCO, before commenting. Thats the way things are.
You have to try to make up your own mind about the market for NP-1 in the cancer pain market or in the broad diabetic neuropatic pain market.
Eqiualent after 4 weeks in PHN to Gabapentin. What will be the outcome after 8 or 12 weeks of treatment? At what week stops the additative efficacy effect? Eight weeks? 10?
The most effective medicine in the diagnosis are now challanged.
The new willingness from Bigpharma to conduct a phase III to check this is described from people in the industry to me as a "new dimension", given the new results.
For what is worth.
>As a statistician, you should always be humble in that each placebo effect is unique ...management can already do a multivariate / meta-analysis .. of course they already know the answer to the question<
Yes, these boys always know already anwers though they have no idea what the question is.You're trying to nebulize here in all length, with a ppor superficial knowlege, that these guys missed the right design
I like the results.
This date is of great importance:
May 18, 6:00 PM (EDT) Abstracts released on ASCO.org
My point is to discuss if there is any danger that the placebo effect of any unique kind could stop the trend that the cream is showing increasing efficacy over time, when every new week is added.
What would the outcome be testing for 8-12 weeks in the broad diagnosis, that is what I am discussing. The pain in cancer diagnosis couldn't have a better outcome?
All the big actors have failed in this diagnosis. I like the p-value here, .001.
There is a saying in Swedish: Much wants more. The cancer patient group that is demanding relief from pain is about 2 million and the broad neuropatic pain group is 15 millions.
Lidoderm gross sales is some 700 million USD per annum for PHD, 200 000 patients. Some off label? :-)
All the best,