NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Hi CD.
Yes, you have probably gathered, I don't really have a lot of regard for the way that the ICI's are being pushed through thousands of trials, when analysis after analysis is showing evidence of HPD that will accelerate tumor growth and death, in anything betweeh 5 and 30% of patients. Trial patients are told nothing about this risk.

The FDA in its continued silence, is effectively denying the issue, and BP is trying to gain maximum commercial advantage while the sun shines (not for patients). It's completely immoral.
Having said that, compared to BMY, Merck seems to have a knack of designing their trials to get approval with the support of a very cooperative FDA.

Not that the drugs necessarily extend survival by any meaningful degree. They frequently don't.
There has been a study that shows that the drugs with the most dubious surrogate endpoint of response rate are also the most expensive.

So to my mind, it's a very unholy battle between the the ICI manufacturers to gain ascendency in the space. And in that battle, Merck seems to win out over BMY nine times out of 10, with a compliant FDA.

My view of the Gottleib speech is very different to most commentators here.
To me, the takeaway message was aimed at BP, the message being; 'you keep running the single arm open-label trials, demonstrate a tumor response rate, and we'll keep approving', and 'We won't expect you to use OS, because it takes too long and denies patients the drug for too long, and you won't need a placebo arm because it's unethical..'

https://www.fda.gov/NewsEvents/Speeches/ucm611623.htm

That speech was at the NCCN, the organisation that writes the treatment guidelines upon which insurance companies make coverage decisions. 80% of NCCN writers receive payments from BP.
And the NCCN make off-label recommendations for drugs far beyond what they were approved for, often with no evidence at all.


https://www.bmj.com/content/360/bmj.k668


Less and less cancer approvals are now based on the the OS gold standard.