NorthWest Biotherapeutics Inc (NWBO)

[ilovetech]

According to Gemini: Yes, regulators do find gene and cell therapies more challenging to review than tablet-based medications. Here's why:
Novelty and Complexity: Gene and cell therapies utilize cutting-edge techniques, making their mechanisms of action more intricate.
Long-Term Effects: Assessing the lasting impact of these therapies is difficult due to their relatively recent introduction.
Safety Concerns: Potential risks like off-target effects or insertional mutagenesis require more scrutiny.
Personalized Nature: Some therapies are tailored to individuals, maing it harder to establish general safety and efficacy standards.

While those of us have known about the safety and efficacy of DCVAX, the application did run a full 1.7 million pages, not out of simplicity imo. As for regulators, it's like a blackbox to me. I have no concept of who, what, how, and where these people have received their training. The best people are not attracted to that kind of thankless high pressure job imo.

As for you putting tablets and gene and cell therapies in the same complexity bucket, I actually looked through mRNA patents casually, back when "news people" were selling us on safety and efficacy." 🤔🤥 I would challenge any physician or regulator to get past, say the first two or three pages, from the 93 representing, just one aspect of the patents, and explain it in simple terms. Forget the lie that they produced the vaccine in 9 months, while all the documents for anyone willing to do basic research will find mRNA vaccine research goes back to the late 90's. It was considered high risk for mutagenesis then, and there's never been long term safety studies to mitigate that concern. When Secretary Pompeo took to the podium at that time, as he was speaking about the circumstances then, as the vaccine was being rolled out, he said, "We're in the middle of a live exercise." Translation: "The population is the live trial." Get it?

It's taking nearly a year to approve the longest trialed, safest, most effective to date, nearly holistic treatment, and were to believe
not only did it not take regulators 3 or 5 years to review just the mRNA application, but even more absurd, that it took 9 months to put it together and release it en mass.

Simple minds die hard.