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Sunday, February 05, 2023 12:33:20 AM
External devices get a far easier time especially if they have no ability to kill or harm. They extrapolated data initially and based on a lot of different factors that simply don’t work for drugs. The reality is, the regulator is less careful with such an external device and the entire process is simply less rigorous and run by entirely different people who are far more permissive if something is safe and vaguely suggests a benefit in a disease like GBM. National insurance review is where the shortcomings are revealed.
I did read the trial inclusion criteria and nowhere did that come up in my reply because I did not dispute it. Trying to imply my being not factual is a great rhetorical trick but is not a valid nor righteous way to argue a point.
The reality is the SAP considers the trials and the FDA knows already there are differences when you use ECA’s and that people will quibble. But the reality is, even with the best surgery, the cancer leaves lots to remain behind, the tumors grow quickly and the analysis compares the partial and total resection patients and makes appropriate comparisons.
There is no mountain and reasonable conclusions can in fact be draw and far better and far more experts than the biased few you try to hold up as the entire world disagree with you. We will have to see if it gets approved but the fact that people spend days and weekends through every day, for years on end trying to rhetorically prove it can’t be approved even before they had the data and then redoubled efforts after a successful peer reviewed publication suggests that critics have far more to fear because if they did not, they’d not need to be so critical and active in opposing and making their paltry case into a “mountain”.
Your false notion of “double dosing” for which you have now recreated a new few words is a false notion. No such thing.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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