NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Gary,

I know you feel that way and it would be nice, but the reason we have science and law determining which drugs come on the market is because feelings are not entirely rational. While something may appear to be a certain way, it still needs to be proved by the standards that existed at that moment in time. Regulators are not emperors and they do not approve drugs by fiat, though it may feel that way at times.

I have never said an ethical partial halt meant NWBO could prove efficacy at that moment, in fact my opinion is the opposite, what the different regulators did because they had different rules and laws applicable, was unfortunate, though without a global regulator, which would necessarily be undemocratic, such overlaps of different regulations are bound to happen. This is why the regulators are trying to coordinate more in different ways.

Also, regulatory reform is in the process of making the rules much better for these circumstances. You know, the 21st Century Cures Act was kept bottled up by the GOP to not let President Obama make any progress. They only allowed it to pass when he was a lame duck so that people might think it was Trump reforming the FDA. This is the result of the cost of our politics, not the FDA.

Our politics are toxic. Lawmakers need to stop being all about one side or the other and winning and try to get actual work done. But you know what, most voters vote for gridlock. They have been told that gridlock is good. So they vote for a president of one party or governor, and then a legislature of the other party, and we get gridlock.

Then every 8-4 years we vote in the other side to rip up everything the side that was just in power accomplished. The problem is not the FDA, it is the miseducation of our voters. Collaboration with many different people of different geographies and backgrounds is what made this nation great. Yet we encourage people to fight when they get in office and we vote for people who “fight” and do not value collaboration with the other side to get things done. That’s a big problem and has been for a long wile. Thankfully when the 21st Century Cures Act passed, it was actually bipartisan. They just kept it bottled up to undermine the President at the time.