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Saturday, June 13, 2015 2:48:19 PM
1. We have the individual differences between the patients for cancer type, how long the survive, and for those who passed, what method treatment they were given. Moreover, we know the group patient characteristics, including the median number of prior treatments, the stage (IV) of cancer and that their cancers were inoperable.
Back to the original question which was:
What was the life expectancy of these patients? You correctly answered that “We do not have patient to patient profile.”
I agree. Even if the expectancy criteria did not change during enrollment, it is still a minimum requirement with no upper limit. Don't you think there was probably a large pool of eligible patients (unfortunately) at one of the largest cancer centers in the world for NWBO to select from? There is evidence to support this from how quickly phase 1 was enrolled and from other comments made by LP about the high level of demand for this trial. I'm not sure how you can dispute this. Are you inferring that selection bias is not a valid consideration for a phase 1 biotech trial?
2. Diagnosed rate of progression is not given, and would not typically be given in a stage I trial until final results are published (if then), but we currently know:
All patients had stage 4, locally advanced or metastatic disease
• Patients had an average of 3 tumor lesions
• Patients had a median of 3.1 prior therapies
Consider, stage IV patients that had already failed 3 prior therapies on average. Bluesky, please come back to me with a phase I trial showing diagnosed rate of progression prior to experimental treatment.
That's all fine. Now back to the original question:
What was the diagnosed rate of progression for these patients? You correctly answered that “Diagnosed rate of progression is not given.”
I agree. I'm not saying that it should have been released or that this is a nefarious strategy for NWBO to keep us in the dark. I'm only saying that it is an unknown factor. I agree that it is not typically something given prior to final results (my straw man radar is starting to flash). Therefore it is currently unknown. Do you agree there could be different PD's for a single group of stage 4 patients? Not sure why you feel it is necessary to defend or dispute this fact. Moving on..
3. We do not know phase I inclusion criteria for minimal survival prognosis was changed during the phase I enrollment. Your hypothesis is that they changed it during phase I enrollment.
I see your point. We don't know for sure if/when it was changed. The information from clinicaltrial.gov supports your theory that it wasn't changed during phase 1, the trial info from MD Anderson cracks the door open for alternative theories. Let me rephrase the question. Do we know if the life expectancy criteria was changed during the phase 1 trial? Answer = unknown Should we ignore the possibility that it may have been and the potential impact such a change could have on length of survival?
4. I gave you the mix of A and B, you are welcome. And even if you took the extreme case, and placed all method B survivors in the lower group of 9-14 months, and method A survivors from 14 to 17 months, they are all still alive! Even under an extreme division like that, both groups would still be doing phenomenally.
Ha, thank you so much for helping me figure out the slides from the presentation!! Gosh, I would be so lost without you. Under your extreme case, if both groups are doing phenomenally, what does that say to you about the efficacy potential of A vs. B. Does it support the "theory" that B is much more potent that A? Does it cast any shadow over the hope that B is the cure we've all been waiting for? Maybe NWBO is foolish to discard A so quickly? If it is working wonders for the longest survivors in the trial, shouldn't they continue to test A in phase 2?
Like it or not, I am on your side (long). Doesn't mean I don't have lingering questions that will hopefully be answered as we go forward. Some advice for you, there's nothing wrong with also busting bullish speculation by saying, sorry charlie some things are still unknown, you will have to wait along with the rest of us. It seems easy for you to do this when picking about the doubters posts. It would actually give you some credibility to use it a little more liberally on both sides. Just saying.
Good day
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