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Friday, February 01, 2019 12:02:15 PM
Thank you again for your effort. As I looked through the answers given numbers 3 and 4 stood out. In number 3, Les mentions FDA as being involved in the hold and yet FDA responded before to an investor query saying that there was no reason NWBO could not divulge the reason for the hold based on anything from FDA. That means that this answer is being witheld for another reason. Now Les may have been pointing to FDA involvement in randomization because the very next question states NWBO has nothing to do with randomization which is true but if a DMC suggests unblinding due to ethical concerns and the company chooses not to then.. FDA and or other regulators get involved. That takes us back to how question 3 was answered. FDA was "involved with" the hold. They did not just impose it.. they were "involved with" it. When does a regulator get involved with instead of just impose or withdraw a hold. Could have been ethical concerns and or conflict of interest based on what sentiment_stocks and others discussed. NWBO initiated the hold outside of the US and it was a snafu in Germany that caused the hold to be discovered in the first place. Then to top everything off the number of patients left out of SOC/placebo essentially match up exactly with the last patients enrolled into treatment on a 2:1 treatment to SOC/placebo ratio. Sorry folks but highly controlled trials seeking good science doesn't lead to highly unlikely coincidences showing up at the last minute. This is all being covered up the best way they could and it has worked pretty well but the numbers are just too obvious. Again, NWBO did not control randomization but regulators could have for the exact reasons mentioned. The multiple trial sites is just made up speculation by an entity not involved in randomization or potential intervention for ethical purposes. The wording by Les in these two answers is about as clear as NWBO is comfortable sharing at this point because beyond this there may be other more sensative factors involved in non disclosure related to the investigation. I nevwr wxpected any direct answers about thd hold because of this. As far as timeline at least Les mentioned a couple of months in each step instead of multiple months as stated before. Best wishes.
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